Vacutainer®

Evacuated Blood Collection System

For In Vitro Diagnostic Use
EN – English
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 Vacutainer®
Evacuated Blood Collection System
For In Vitro Diagnostic Use

INTENDED USE BD Vacutainer® Trace Element Tubes Contamination Upper Limits

BD Vacutainer® Tubes, Needles and Holders are used together as a system for the collection Analyte Glass µg/L Plus µg/L Analyte Glass µg/L Plus µg/L
of venous blood. BD Vacutainer® Tubes are used to transport and process blood for testing Antimony 0.8 -* Lead 2.5 0.3
serum, plasma or whole blood in the clinical laboratory. Arsenic 1.0 0.2 Magnesium 60 40
PRODUCT DESCRIPTION Cadmium 0.6 0.1 Manganese 1.5 1.5
BD Vacutainer® Tubes are evacuated tubes with color-coded conventional stoppers or Calcium 400 150 Mercury** - 3.0
BD Hemogard™ Closures. BD Vacutainer® Plus Tubes are plastic tubes.
Chromium 0.9 0.5 Selenium - 0.6
Most tube types contain additives in varying concentrations dependent upon the amount of
vacuum and the required additive to blood ratio for the tube. See each shelf package or case Copper 8.0 5.0 Zinc 40 40
label for specific additive quantity and approximate draw volume. Additive choice depends Iron 60 25
on the analytic test method. It is specified by the manufacturer of the test reagents and/ *BD Vacutainer® Trace Element Plus Tubes should not be used for antimony testing.
or instrument on which the test is performed. Tube interiors are sterile. Tube stoppers are Water extraction analyzed by **Cold Vapor, all others Inductively Coupled Plasma-Mass Spectrometry
lubricated with silicone or glycerin (see individual shelf package or case label) to facilitate (ICP-MS) or Atomic Absorption Spectroscopy (AAS).
stopper insertion.
BD Vacutainer® SST™ Tubes / BD Vacutainer® SST™ II Advance Tubes*
BD Vacutainer® Blood Collection Tube Reference* The interior of the tube wall is coated with micronized silica particles to accelerate clotting.
A barrier polymer is present at the tube bottom. The density of this material causes it to
ADDITIVE GROUP/ADDITIVE move upward during centrifugation to the serum-clot interface, where it forms a barrier
Gel Separation Tubes separating serum from fibrin and cells. Serum may be aspirated directly from the collection
tube, eliminating the need for transfer to another container. A silicone coating on the inner
BD SST™ Tubes with Gel and Clot Activator
tube wall reduces adherence of red cells to tube walls. See Limitations of System, Precautions,
BD PST™ Tubes with Gel and Lithium HeparinN 1 Specimen Collection and Handling Sections.
BD SST™ ll Advance Tubes with Gel and Clot Activator**
*May not be available in the U.S.
BD PST™ ll Tubes with Gel and Lithium HeparinN 1**
Non-Additive Tubes BD Vacutainer® PST™ Tubes / BD Vacutainer® PST™ II Tubes*
Silicone Coated** The interior of the tube wall is coated with lithium heparin to inhibit clotting. Heparin activates
Uncoated** antithrombins, thus blocking the coagulation cascade and producing a whole blood/plasma
sample instead of clotted blood and serum. A barrier polymer is present at the tube bottom.
No Additive2
The density of this material causes it to move upward during centrifugation to the plasma-cell
Serum Tubes with Additives interface, where it forms a barrier separating plasma from cells. Plasma may be aspirated
Thrombin3** directly from the collection tube, eliminating the need for transfer to another container. See
Plus Serum/CAT with Clot Activator Limitations of System, Precautions, Specimen Collection and Handling Sections.
Thrombin3, Soybean Trypsin Inhibitor** *May not be available in the U.S.
Sodium Fluoride** BD Vacutainer® Tubes for Blood Banking
Whole Blood/Plasma Tubes BD Vacutainer® Plus Serum Tubes, BD Vacutainer® Plus K2EDTA Tubes, BD Vacutainer®
K2EDTA or K3EDTA*** Glass Serum Tubes, and BD Vacutainer® Glass K3EDTA Tubes, may be used for routine
K2EDTA*** immunohematology testing such as ABO grouping, Rh typing, antibody screening, red cell
Citrate/CTAD (Coagulation) phenotyping and DAT testing, and blood donor screening for infectious disease such as Syphilis
Citrate (ESR) Ab, anti-HIV, anti-HTLV, anti-HCV, anti-HBc, and HBsAg. The performance characteristics of
Sodium Fluoride/Sodium EDTA** these tubes have not been established for immunohematology testing and infectious disease
Sodium Fluoride/Potassium Oxalate testing in general; therefore, users must validate the use of these tubes for their specific assay-
HeparinN 1*** instrument/reagent system combinations and specimen storage conditions.
Acid Citrate Dextrose (ACD) BD Vacutainer® SST™ Plus Tubes, BD Vacutainer® SST™ Glass Tubes and BD Vacutainer® SST™
II Advance Tubes may be used for routine blood donor screening and diagnostic testing of
Trace Element Tubes**** serum for infectious disease such as ToRCH, Syphilis Ab, anti-HIV, anti-HTLV, anti-HCV, anti-HBc,
Silicone Coated**, HeparinN 1**, K2EDTA or with clot activator and HBsAg. The performance characteristics of these tubes have not been established for
*Closure color may vary for specific reorder numbers. infectious disease testing in general; therefore, users must validate the use of these tubes for
**May not be available in the U.S. their specific assay-instrument/reagent system combinations and specimen storage conditions.
1
HeparinN source is porcine. Devices labeled with a superscript letter ‘N’ indicate that
the device contains heparin which has been certified to meet the requirements of USP BD Vacutainer® CTAD Tubes
Heparin Monograph October 1, 2009. The CTAD tube is used for the collection and transport of specimens for hemostasis testing.
2
May only be used as a discard tube or as a secondary specimen collection tube. The CTAD solution is a mixture of sodium citrate, theophylline, adenosine and dipyridamole.
The purpose of the additive is to anticoagulate the specimen and to minimize in vitro platelet
3
Thrombin source is bovine. activation. See Precautions, Specimen Collection and Handling Sections.
***BD Vacutainer® EDTA tubes and Lithium Heparin tubes are not recommended for use
with Magellan Diagnostics LeadCare® assays, employing the Anodic Stripping BD Vacutainer® Plus Citrate Tubes
Voltammetry (ASV) methodology, or any other assay employing ASV methodology. The tube component is comprised of two plastic tubes assembled together to maintain the
****For trace element testing including lead testing of venous blood, BD recommends draw volume and liquid additive. The tube contains buffered sodium citrate additive. All tube
using BD Vacutainer® Trace Element Testing Tube. configurations are full draw and utilize BD Hemogard™ Closures. See Limitations of System,
Precautions, Specimen Collection and Handling Sections. The product performance has
been compared to the 4.5mL glass tube for routine coagulation assays on a variety of donor
BD Vacutainer® Serum Tubes populations with clinically equivalent results obtained. Note: all studies were performed on
BD Vacutainer® Plus Serum Tubes / CAT Tubes are coated with silicone and micronized silica donors with hematocrits between 25 and 55%.
particles to accelerate clotting. Particles in the white film on the interior surface activate The tube is designed to ensure appropriate fill level. Always allow the tube to fill until the
clotting when tubes are mixed by inversions. A silicone coating on the walls of most serum blood ceases to flow. Information on correct tube fill level is provided below.
tubes reduces adherence of red cells to tube walls. See Limitations of System, Precautions,
Specimen Collection and Handling Sections. Minimum Fill Indicator:
BD Vacutainer® Tubes for Trace Element Tests The 360° etched fill indicator on the tube represents the minimum volume of blood required
for appropriate analysis. Check that the blood level is at or above the bottom edge of the
Tubes for trace element testing including lead testing are labeled specifically for this purpose minimum fill indicator.
on the shelf package and case label. Use only appropriately labeled tubes for these tests. The
tubes for trace element testing have been tested by extraction of the stoppered tube for Maximum Fill Level Guidance:
4 hours, yielding results below these concentration limits: For the 2.7 mL tube, if blood meniscus is not visible per the figure below, the tube is considered
overfilled.

2 (Continued)
For the 1.8 mL tube, if blood meniscus is higher than level shown in the figure below, the tube 5. CTAD tubes must be protected from artificial and natural light during storage.
is considered overfilled. The meniscus must be at least a distance of 3 mm from the bottom Accumulated light exposure in excess of 12 hours can cause additive inactivation.
edge of the closure as shown in the figure below. 6. Separation of serum or plasma from the cells should take place within 2 hours of
collection to prevent erroneous test results unless conclusive evidence indicates that
longer contact times do not contribute to result error.
Maximum fill
7. Do not use luer adapters for connection to indwelling catheters/ports; use a
point Distance BD Vacutainer® Luer‑Lok™ Access Device instead.
Ensure from
blood
cap to
max line
8. BD Vacutainer® EDTA tubes and Lithium Heparin tubes are not recommended for use with
360 °etched
meniscus
is visible minimum
3 mm Magellan Diagnostics LeadCare® assays, employing the Anodic Stripping Voltammetry
fill indicator
Always allow the (ASV) methodology, or any other assay employing ASV methodology.
tube to fill until
the blood ceases 9. Reinsertion of the BD Hemogard™ Closure is not recommended for BD Vacutainer®
to flow
Check that the
Thrombin Tube (Ref 367817). Reinsertion could increase the risk of specimen exposure due
blood level is at or
above the bottom
to closure not remaining securely on the tube during handling.
edge of the minimum
fill indicator. CAUTION:
1. Practice Universal Precautions. Use gloves, gowns, eye protection, other personal
2.7 mL draw tube 1.8 mL draw tube
protective equipment, and engineering controls to protect from blood splatter, blood
13 x 75 mm 13 x 75 mm leakage, and potential exposure to bloodborne pathogens.
2. All glass has the potential for breakage. Examine all glass for potential damage in transit
before use, and take precautionary measures during handling.
BD Vacutainer® Blood Collection Needles 3. Handle all biologic samples and blood collection “sharps” (lancets, needles, luer adapters,
and blood collection sets) according to the policies and procedures of your facility. Obtain
BD Vacutainer® Blood Collection Needles are single-use, double-ended, medical grade stainless appropriate medical attention in the event of any exposure to biologic samples (for example,
steel needles. They have a threaded hub that fits into the threads of all BD Vacutainer® Holders. through a puncture injury), since they may transmit viral hepatitis, HIV (AIDS), or other
The venipuncture end of the needle has a point specially designed to enter the skin easily during infectious diseases. Utilize any built-inused needle protector, if the blood collection device
venipuncture. The needle is lubricated with silicone. The needles are available in 1 and 1-1/2 inch provides one. BD does not recommend reshielding used needles. However, the policies and
lengths in 20, 21 and 22 gauge*; blood collection sets are available in 3/4 inch lengths in 21, 23 procedures of your facility may differ and must always be followed.
and 25 gauge, BD Vacutainer® Passive Shielding Blood Collection Needles in 1 inch and 21 and
22 gauge and BD Vacutainer® Eclipse™ in 1-1/4 inch and 21 and 22 gauge. Needle size and lot 4. Discard all blood collection “sharps” in biohazard containers approved for their disposal.
number are printed on each individual needle assembly. 5. Transferring a sample collected using syringe and needle to a tube is not recommended.
*Not available in the U.S. Additional manipulation of sharps, such as hollow bore needles, increases the potential
BD Vacutainer® Luer Adapter, BD Vacutainer® Luer-Lok™ Access Device, and BD Vacutainer® for needlestick injury.
Blood Transfer Device are products designed with a luer fitting in place of the venipuncture 6. Transferring samples from syringe to an evacuated tube using a non-sharps device should
end of the needle. The BD Vacutainer® Luer Adapter is a male slip-luer fitting opposing a be performed with caution for the reasons described below. • Depressing the syringe
multiple sample non-patient (NP) needle. It is designed to be used with a BD Vacutainer® plunger during transfer can create a positive pressure, forcefully displacing the stopper
Holder. The BD Vacutainer® Luer-Lok™ Access Device is a holder with an integrated multiple and sample, causing splatter and potential blood exposure. • Using a syringe for blood
sample NP needle and threaded male luer fitting. The BD Vacutainer® Blood Transfer Device transfer may also cause over or under filling of tubes, resulting in an incorrect blood-to-
is a holder with an integrated multiple sample NP needle and locking female luer fitting. additive ratio and potentially incorrect analytic results. • Evacuated tubes are designed to
Products have a latex free sleeve covering the NP needle that prevents leakage of blood into draw the volume indicated. Filling is complete when vacuum no longer continues to draw,
the holder during blood collection. The tubes slide into the holder and are pushed onto the NP though some tubes may partially fill due to plunger resistance when filled from a syringe.
needle, allowing the vacuum in the tube to draw blood to a predetermined level. The laboratory should be consulted regarding the use of these samples.
7. If blood is collected through an intravenous (I.V.) line, ensure that line has been cleared
LIMITATIONS OF SYSTEM of I.V. solution before beginning to fill blood collection tubes. This is critical to avoid
The quantity of blood drawn varies with altitude, ambient temperature, barometric pressure, erroneous laboratory data from I.V. fluid contamination.
tube age, venous pressure, and filling technique. Tubes with draw volume smaller than the 8. Overfilling or under filling of tubes will result in an incorrect blood-to-additive ratio and
apparent dimensions indicated (partial draw tubes), may fill more slowly than tubes of the may lead to incorrect analytic results or poor product performance.
same size with greater draw volume. 9. Endotoxin not controlled. Blood and blood components collected and processed in the
For tubes subjected to centrifugation to generate plasma or serum for testing, standard tube are not intended for infusion or introduction into the human body.
processing conditions do not necessarily completely sediment all cells, whether or not barrier gel
is present. Cell–based metabolism, as well as natural degradation ex vivo, can continue to affect STORAGE
serum/plasma analyte concentrations/activities after centrifugation. Separated plasma samples Store tubes at 4-25ºC (39-77ºF), unless otherwise noted on the package label. All liquid
in particular, will have a gradient of cells and platelets present after centrifugation. The presence preservatives and anticoagulants are clear and colorless, except CTAD which is yellow. Do not
of cells and platelets in the plasma may lead to increased variability and/or instability of certain use if they are discolored or contain precipitates. Powdered additives such as heparin and
analytes that are involved in cell/platelet–mediated metabolic processes and/or are present thrombin are white; fluoride and fluoride/oxalate may be pale pink. Do not use if color has
in higher concentrations in cells or platelets. Analytes that may be affected include aspartate changed. EDTA spray coated additives may have a white to slightly yellow appearance; this
aminotransferase, glucose, inorganic phosphorus, lactate dehydrogenase and potassium. The does not affect the performance of the EDTA additive. Do not use tubes after their expiration
magnitude of such effects may vary depending on several factors, including whether the plasma date. Tubes expire on the last day of the month and year indicated.
is aliquoted or remains in the primary tube, sample agitation, and time. Analyte stability should
be evaluated for the storage containers and conditions of each laboratory. SPECIMEN COLLECTION AND HANDLING
BD Vacutainer® PST™ Plus Tubes, BD Vacutainer® PST™ Glass Tubes and BD Vacutainer® READ THIS ENTIRE CIRCULAR BEFORE PERFORMING VENIPUNCTURE.
PST™ II Tubes are not recommended for the collection of samples for blood banking Required Equipment Not Provided for Specimen Collection
procedures. BD Vacutainer® SST™ Plus Tubes, BD Vacutainer® SST™ Glass Tubes and
BD Vacutainer® SST™ II Advance Tubes are not recommended for immunohematology 1. Practice Universal Precautions. Use gloves, eye protection, coats or gowns, and other
testing. BD Vacutainer® SST™ Plus Tubes and BD Vacutainer® SST™ II Advance Tubes appropriate apparel for protection from exposure to bloodborne pathogens or other
can be used for certain TDM assays. U.S. customers please contact BD Technical Services potentially infectious materials.
Department at 1-800-631-0174 for details, outside the U.S. contact your local representative. 2. Any BD Vacutainer® Needle Holders of the standard size may be used with 13 or 16 mm
Do not use BD Vacutainer® Tubes containing lithium heparin for lithium measurement. diameter tubes. A pediatric tube adapter should be used to modify the standard holder to
For coagulation tests, if patient hematocrit is above 55%, the final citrate concentration fit the 10.25 mm diameter tubes.
in the specimen should be adjusted. 3. Alcohol swab for cleansing site. If additional tubes requiring sterile collections, such as
Venous blood gas samples collected with BD Vacutainer® Plastic Lithium Heparin tubes blood cultures, are filled from the same venipuncture, use tincture of iodine or suitable
should not be used when testing carboxyhemoglobin (COHb) using the IL GEM 4000 alternative for cleansing. Follow the laboratory policy for sterile sample collection for site
instrument. A clinically significant positive bias with COHb results may occur. preparation and tube handling instructions. Do not use alcohol based cleansing materials
when samples are to be used for blood alcohol testing.
PRECAUTIONS 4. Dry, clean disposable gauze.
1. Storage of glass tubes containing blood at or below 0ºC may result in tube breakage. 5. Tourniquet.
2. Do not remove conventional rubber stoppers by rolling with thumb. Remove stoppers with 6. Needle disposal container for used needle or needle/holder combination.
a twist and pull motion.
Required Equipment Not Provided for Specimen Processing
3. Do not use tubes or needles if foreign matter is present.
1. Disposable transfer pipets if direct sampling from the instrument is not used or if specimen
4. The paper label covering the connection of the needle shields will tear when the needle is is stored separately.
opened. Do not use needle if label has been torn before venipuncture.
3 (Continued)
2. Centrifuge capable of generating the recommended RCF at the tube bottom. A horizontal 13. While each successive tube is filling, turn the filled tube upside-down and return it to
centrifuge head is preferred for barrier quality with gel tubes and to obtain platelet poor upright position. This is one complete inversion.
plasma for coagulation studies. For proper additive performance, invert BD SST™ Tubes or Plus Serum Tubes 5 times. Invert
3. Gloves and other personal protective equipment as necessary for protection from exposure BD CAT Tubes 5-6 times. Invert BD SST™ II Advance Tubes 6 times. Invert Citrate or CTAD
to bloodborne pathogens. tubes 3-4 times. Invert all other filled additive tubes 8-10 times. Do not shake. Vigorous
Preparation for Specimen Collection mixing may cause foaming or hemolysis. Insufficient mixing or delayed mixing in serum
tubes may result in delayed clotting and incorrect test results. In tubes with anticoagulants,
Be sure the following materials are readily accessible before performing venipuncture: inadequate mixing may result in platelet clumping, clotting and/or incorrect test results.
1. See Required Equipment Not Provided for Specimen Collection above. 14. As soon as blood stops flowing in the last tube, remove tube from holder, remove needle
2. All necessary tubes, identified for size, draw, and additive. from vein, applying pressure to puncture site with dry sterile swab until bleeding stops.
3. Labels for positive patient identification of samples. 15. Once clotting has occurred, apply bandage if desired.
Recommended Order of Draw 16. After venipuncture, the top of the stopper may contain residual blood. Take proper
1. Tubes for sterile samples. precautions when handling tubes to avoid contact with this blood.
2. Tubes for coagulation studies (e.g., citrate). 17. Dispose of needle and holder per your facility’s policy and guidelines.
3. BD SST™, BD SST™ II Advance and Serum Tubes. Clotting Instructions
4. Tubes with other additives (e.g., heparin, EDTA, fluoride). Allow blood to clot thoroughly before centrifugation. The following table gives the
recommended minimum clotting times for specific tube types or additives.
When using a winged blood collection set for venipuncture and a coagulation (citrate) tube is
the first specimen tube to be drawn, a discard tube should be used prior to the first specimen Minimum Clotting Time Recommendations
collection. The discard tube must be used to fill the blood collection set tubing’s “dead space” PRODUCT TIME (min)
with blood. The discard tube does not need to be filled completely. This step will ensure
maintenance of the proper blood-additive-ratio of the specimen. The discard tube should be Serum / CAT Tubes 60
a non additive or coagulation tube. BD Vacutainer® SST™ Tubes, BD Vacutainer® SST™ II BD SST™ / BD SST™ II Advance Tubes 30
Advance Tubes and BD Vacutainer® Plus Serum Tubes / CAT Tubes contain particulate clot Thrombin Tubes 5
activators and are considered additive tubes. Therefore, Plus Serum Tubes are not to be used
Recommended times are based upon an intact clotting process. Patients with abnormal
as discard tubes before drawing citrate tubes for coagulation studies.
clotting due to disease, or those receiving anticoagulant therapy require more time for
Prevention of Backflow complete clot formation.
Since some evacuated blood collection tubes contain chemical additives, it is important to
Centrifugation
avoid possible backflow from the tube, with the possibility of adverse patient reactions.
To guard against backflow, observe the following precautions: Caution: Do not centrifuge glass tubes at forces above 2200 RCF in a horizontal head (swinging
1. Place patient’s arm in a downward position. bucket) centrifuge as breakage may occur. Glass tubes may break if centrifuged above 1300
RCF in fixed angle centrifuge heads. BD Vacutainer® Plus Tubes will withstand up to 10,000 RCF
2. Hold tube with the stopper uppermost. in a balanced centrifuge. Always use appropriate carriers or inserts. Use of tubes with cracks
3. Release tourniquet as soon as blood starts to flow into tube. or chips or excessive centrifugation speed may cause tube breakage, with release of sample,
4. Make sure tube additives do not touch stopper or end of the needle during venipuncture. droplets, and an aerosol into the centrifuge bowl. Release of these potentially hazardous
materials can be avoided by using specially designed sealed containers in which tubes are held
Venipuncture Technique and Specimen Collection General Instructions during centrifugation. Centrifuge carriers and inserts should be of the size specific to the tubes
WEAR GLOVES DURING VENIPUNCTURE AND WHEN HANDLING BLOOD COLLECTION TUBES used. Use of carriers too large or too small for the tube may result in breakage.
TO MINIMIZE EXPOSURE HAZARD. RCF is related to centrifuge speed setting (rpm) using the following equation:
1. Select tube or tubes appropriate for required specimen. For sterile collections, see the
specific instructions noted in the collection device product circular. where “r”, expressed in cm, is the radial distance from the
2. Assemble needle in holder. Be sure needle is firmly seated to ensure needle does not center of the centrifuge head to the bottom of the tube.
unthread during use.
3. Gently tap tubes containing additives to dislodge any material that may be adhering to The following table gives recommended centrifuge RCF and time:
the stopper. Centrifugation RCF and Time*
4. Place tube into holder. Note: Do not puncture stopper. PRODUCT RCF (g) TIME (min)
5. Select site for venipuncture.
BD SST™ and BD PST™ Tubes (glass) 1000 – 1300 10
6. Apply tourniquet. Prepare venipuncture site with an appropriate antiseptic. DO NOT
PALPATE VENIPUNCTURE AREA AFTER CLEANSING. BD SST™ Plus and BD PST™ Plus Tubes - 13mm 1100 – 1300 10
7. Place patient’s arm in a downward position. BD SST™ Plus and BD PST™ Plus Tubes - 16mm 1000 – 1300 10
BD SST™ Transport Tubes 1100 – 1300 15
BD SST™ II Advance and BD PST™ II Tubes 1300 – 2000 10
All Non-gel Tubes ≤ 1300 10
Citrate Tubes (glass) 1500** 15**
Citrate Plus Tubes 2000 – 2500** 10 – 15**
8. Remove needle shield. Perform venipuncture WITH ARM DOWNWARD AND TUBE 15 minutes for all gel tubes in a fixed angle centrifuge
STOPPER UPPER-MOST.
RCF = Relative Centrifuge Force, g’s
9. Center tubes in holder when penetrating the stopper to prevent sidewall penetration and
resultant premature vacuum loss. Push tube onto needle, puncturing stopper diaphragm. *Use of alternate centrifugation conditions (e.g., higher RCF and shorter spin time) may also
provide acceptable performance; this should be evaluated and validated by the laboratory.
10. REMOVE TOURNIQUET AS SOON AS BLOOD APPEARS IN TUBE. DO NOT ALLOW CONTENTS **Citrate tubes should be centrifuged at a speed and time to consistently produce platelet-
OF TUBE TO CONTACT THE STOPPER OR END OF THE NEEDLE DURING PROCEDURE. poor plasma (platelet count <10,000/μL) per CLSI Guidelines.
Note: Blood may occasionally leak from the needle sleeve. Practice Universal Precautions to Ensure that tubes are properly seated in the centrifuge carrier. Incomplete seating could result
minimize exposure hazard. If no blood flows into tube or if blood ceases to flow before an adequate in separation of the BD Hemogard™ Closures from the tube or extension of the tube above the
specimen is collected, the following steps are suggested to complete satisfactory collection: carrier. Tubes extending above the carrier could catch on centrifuge head, resulting in breakage.
a. Push tube forward until tube stopper has been penetrated. If necessary, hold in place to Balance tubes to minimize the chance of glass breakage. Match tubes to tubes of the same fill
ensure complete vacuum draw. level, glass tubes to glass, tubes with BD Hemogard™ Closures to others with the Closure, gel
b. Confirm correct position of needle cannula in vein. tubes to gel tubes, BD Vacutainer® Plus Tubes with Plus Tubes, and tube size to tube size.
c. REMOVE TUBE AND PLACE NEW TUBE INTO THE HOLDER. Always allow centrifuge to come to a complete stop before attempting to remove tubes.
d. If second tube does not draw, remove needle and discard. Repeat procedure from Step 1. When centrifuge head has stopped, open the lid and examine for possible broken tubes. If
breakage is indicated, use mechanical device such as forceps or hemostat to remove tubes.
11. When first tube has filled to its stated volume and blood flow ceases, remove it from holder. Caution: Do not remove broken tubes by hand.
12. Place succeeding tubes in holder, puncturing diaphragm to begin flow. See Recommended See centrifuge instruction manual for disinfection instructions.
Order of Draw.
4 (Continued)
Barrier Information SYMBOL AND MARK KEY
The flow properties of the barrier material are temperature-related. Flow may be impeded Authorized representative in the European Community
if chilled before or during centrifugation. To optimize flow and prevent heating during
centrifugation, set refrigerated centrifuges to 25ºC (77ºF). Batch code

Tubes should not be re-centrifuged once barrier has formed. Barriers are more stable when tubes Biological risks
are spun in centrifuges with horizontal (swinging bucket) heads than those with fixed angle heads.
Separated serum or plasma is ready for use. The tubes may be placed directly on the CE marking; Signifies European technical conformity
instrument carrier or serum/plasma may be pipetted into an analyzer cup. Some instruments Catalogue number
can sample directly from a separator tube with the stopper in place. Follow the instrument
manufacturer’s instructions. Caution

ANALYTIC EQUIVALENCY Consult instructions for use or consult electronic instructions for use
Evaluations of BD Vacutainer® Tubes have been performed for an array of analytes over a
Date of manufacture
variety of test methods and time periods. BD Life Sciences - Integrated Diagnostic Solutions
is available to answer questions regarding these studies. Please contact them to obtain
Do not re‑use
references and technical reports on these evaluations and any other information regarding
the use of BD Vacutainer® Tubes with your instrument/reagent system.
For IVD performance evaluation only
TECHNICAL SERVICES
Fragile, handle with care
In the U.S. please contact:
Technical Services In vitro diagnostic medical device
BD Life Sciences - Integrated Diagnostic Solutions Keep away from sunlight
1 Becton Drive
Franklin Lakes, NJ 07417 Manufacturer
1.800.631.0174
bd.com/ifu Sterile
Sterilized using ethylene oxide
Outside the U.S. please contact your local BD representative.
Sterilized using irradiation
Whenever changing any manufacturer’s blood collection tube type, size, handling,
Sterilized using steam or dry heat
processing or storage condition for a particular laboratory assay, the laboratory personnel
should review the tube manufacturer’s data and their own data to establish/verify the Temperature limit
reference range for a specific instrument/reagent system. Based on such information, the
laboratory can then decide if a change is appropriate. Lower limit of temperature

REFERENCES Upper limit of temperature

CLSI Document H1-A6. Tubes and Additives for Venous and Capillary Blood Specimen Collection;
approved standard, 6th ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2010. This way up

CLSI Document H3-A6. Procedures for the Collection of Diagnostic Blood Specimens by
Use‑by date
Venipuncture; approved standard, 6th ed. Wayne, PA: Clinical and Laboratory Standards
Institute; 2007.
Do not use if package is damaged and consult instructions for use
Landt M, Smith CH and Hortin GL. Evaluation of evacuated blood-collection tubes:
Effects of three types of polymeric separators on therapeutic drug-monitoring specimens. Recyclable
Clin Chem 1993; 39:1712-1717.
CAUTION! CTAD Tubes must be protected from artificial and natural light during storage.
Dasgupta A, Dean R, Saldana S, Kinnaman G and McLawhon RW. Absorption of therapeutic drugs Preliminary data indicate unacceptable photoinactivation of dipyridamole after 48 hours
by barrier gels in serum separator blood collection tubes. Am J Clin Path 1994; 101:456-461. exposure to fluorescent light.

Yawn BP, Loge C and Dale J. Prothombin time, one tube or two? Am J Clin Path 1996; 105:794-97. Authorised Representative in Switzerland

Gottfried, EL and Adachi, MM. Prothrombin time (PT) and activated partial prothrombin Importer
time (APTT) can be performed on the first tube. Am J Clin Path 1997; 107:681-683.
CLSI Document H21-A5. Collection, Transport, and Processing of Blood Specimens for CHANGE HISTORY
Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Revision Date Change Summary
approved guideline, 5th ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
07 2023-03 Updated PRECAUTIONS section.
CLSI Document H18-A4. Procedures for the Handling and Processing of Blood Specimens for Added CH REP, and Importer addresses.
Common Laboratory Tests; approved guideline, 4th ed. Wayne, PA: Clinical and Laboratory Updated EC REP symbol and address.
Standards Institute; 2010. Updated SYMBOL AND MARK KEY section.
Instructions for Removal of BD Hemogard™ Closure
Becton, Dickinson and Company, Belliver Industrial Estate, Belliver Way, Roborough
1. Grasp the BD Vacutainer® Tube with one Plymouth PL6 7BP United Kingdom
hand, placing the thumb under the BD Switzerland Sàrl
BD Hemogard™ Closure. (For added Route de Crassier 17, Business Park Terre-Bonne, Batiment A4
stability, place arm on solid surface). With 1262 Eysins, Switzerland
the other hand, twist the BD Hemogard™ BD Switzerland Sàrl
Closure while simultaneously pushing up with the thumb of the other hand ONLY UNTIL Route de Crassier 17, Business Park Terre-Bonne, Bâtiment A4
THE TUBE STOPPER IS LOOSENED. 1262 Eysins, Switzerland
2. Move thumb away before lifting closure. DO NOT use thumb to push closure off tube. Australian and New Zealand Sponsors:
Caution: Any glass tube has the potential to crack or break. If the tube contains Becton Dickinson Pty Ltd.
66 Waterloo Road
blood, an exposure hazard exists. To help prevent injury during closure removal, it is Macquarie Park NSW 2113, Australia
important that the thumb used to push upward on the closure be removed from contact
Becton Dickinson Limited
with the tube as soon as the BD Hemogard™ Closure is loosened. 14B George Bourke Drive
3. Lift closure off tube. In the unlikely event of the plastic shield separating from the rubber Mt. Wellington Auckland 1060, New Zealand
stopper, DO NOT REASSEMBLE CLOSURE. Carefully remove rubber stopper from tube. Made in USA or UK
Instructions for Reinsertion of BD Hemogard™ Closure Becton Dickinson AG Becton Dickinson Distribution Center NV
Binningerstrasse 94 Laagstraat 57
1. Replace closure over tube. 4123 Allschwil, Switzerland 9140 Temse, Belgium
2. Twist and push down firmly until stopper is fully reseated. BD, the BD Logo, Hemogard, Luer-Lok, PST, SST, and Vacutainer are trademarks
Complete reinsertion of the stopper is necessary for the of Becton, Dickinson and Company or its affiliates. All other trademarks are the 2023-03
closure to remain securely on the tube during handling. property of their respective owners. © 2023 BD. All rights reserved. VDP40384(07)