Pas VDP40445 Ifu
Pas VDP40445 Ifu
Vacutainer ®
INTENDED USE
BD Vacutainer® Tubes, Needles and Holders are used together as a system for the collection Most tube types contain additives in varying concentrations dependent upon the amount of
of venous blood. BD Vacutainer® Tubes are used to transport and process blood for testing vacuum and the required additive to blood ratio for the tube. See each shelf package or case
serum, plasma or whole blood in the clinical laboratory. label for specific additive quantity and approximate draw volume. Additive choice depends
PRODUCT DESCRIPTION on the analytic test method. It is specified by the manufacturer of the test reagents and/
or instrument on which the test is performed. Tube interiors are sterile. Tube stoppers are
BD Vacutainer® Tubes are evacuated tubes with color-coded (see table below) conventional lubricated with silicone or glycerin (see individual shelf package or case label) to facilitate
stoppers or BD Hemogard™ Closures. BD Vacutainer® Plus Tubes are plastic tubes. stopper insertion.
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BD Vacutainer® Trace Element Tubes Contamination Upper Limits
Analyte Glass µg/L Plus µg/L Analyte Glass µg/L Plus µg/L
Antimony 0.8 -* Lead 2.5 0.3
Maximum fill
Arsenic 1.0 0.2 Magnesium 60 40 point Distance
Ensure from
Cadmium 0.6 0.1 Manganese 1.5 1.5 blood
360 °etched
cap to
max line
meniscus 3 mm
Calcium 400 150 Mercury** - 3.0 is visible minimum
fill indicator
Always allow the
Chromium 0.9 0.5 Selenium - 0.6 tube to fill until
the blood ceases
to flow
Copper 8.0 5.0 Zinc 40 40 Check that the
blood level is at or
Iron 60 25 above the bottom
edge of the minimum
*BD Vacutainer® Trace Element Plus Tubes should not be used for antimony testing. fill indicator.
Water extraction analyzed by **Cold Vapor, all others ICP-MS
BD Vacutainer® Tubes for Lead Testing Contamination Upper Limits 2.7 mL draw tube
13 x 75 mm
1.8 mL draw tube
13 x 75 mm
Analyte Glass µg/L Plus* µg/L
Lead 10 2.5 BD Vacutainer® Blood Collection Needles
0.1N nitric acid extraction analyzed by ICP-MS BD Vacutainer® Blood Collection Needles are single-use, double-ended, medical grade stain-
*Also suitable for routine hematology testing less steel needles. They have a threaded hub that fits into the threads of all
BD Vacutainer® Holders. The venipuncture end of the needle has a point specially designed to
BD Vacutainer® SST™ Tubes enter the skin easily during venipuncture. The needle is lubricated with silicone. The needles
The interior of the tube wall is coated with micronized silica particles to accelerate clotting. are available in 1 and 1-1/2 inch lengths in 20 and 21 gauge; blood collection sets are avail-
A barrier polymer is present at the tube bottom. The density of this material causes it to able in 3/4 inch lengths in 21, 23 and 25 gauge, BD Vacutainer® Passive Shielding Blood Col-
move upward during centrifugation to the serum-clot interface, where it forms a barrier lection Needles in 1 inch and 21 and 22 gauge and BD Vacutainer® Eclipse™ in 1-1/4 inch and
separating serum from fibrin and cells. Serum may be aspirated directly from the collection 21 and 22 gauge. Needle size and lot number are printed on each individual needle assembly.
tube, eliminating the need for transfer to another container. A silicone coating on the inner
tube wall reduces adherence of red cells to tube walls. See Limitations of System, Precautions, BD Vacutainer® Luer Adapter, BD Vacutainer® Luer-Lok™ Access Device, and
Specimen Collection and Handling Sections. BD Vacutainer® Blood Transfer Device are products designed with a luer fitting in place of
the venipuncture end of the needle. The BD Vacutainer® Luer Adapter is a male slip-luer
BD Vacutainer® PST™ Tubes fitting opposing a multiple sample non-patient (NP) needle. It is designed to be used with
The interior of the tube wall is coated with lithium heparin to inhibit clotting. Heparin a BD Vacutainer® Holder. The BD Vacutainer® Luer-Lok™ Access Device is a holder with an
activates antithrombins, thus blocking the coagulation cascade and producing a whole blood/ integrated multiple sample NP needle and threaded male luer fitting. The BD Vacutainer®
plasma sample instead of clotted blood and serum. A barrier polymer is present at the tube Blood Transfer Device is a holder with an integrated multiple sample NP needle and locking
bottom. The density of this material causes it to move upward during centrifugation to the female luer fitting.
plasma-cell interface, where it forms a barrier separating plasma from cells. Plasma may be
Products have a latex free sleeve covering the NP needle that prevents leakage of blood into
aspirated directly from the collection tube, eliminating the need for transfer to another con-
the holder during blood collection. The tubes slide into the holder and are pushed onto the NP
tainer. See Limitations of System, Precautions, Specimen Collection and Handling Sections.
needle, allowing the vacuum in the tube to draw blood to a predetermined level.
BD Vacutainer® Tubes for Blood Banking
LIMITATIONS OF SYSTEM
BD Vacutainer® Plus Serum Tubes, BD Vacutainer® Plus K2EDTA Tubes, BD Vacutainer®
The quantity of blood drawn varies with altitude, ambient temperature, barometric pressure,
Glass Serum Tubes, and BD Vacutainer® Glass K3EDTA Tubes, may be used for routine
tube age, venous pressure, and filling technique. Tubes with draw volume smaller than the
immunohematology testing such as ABO grouping, Rh typing, antibody screening, red cell
apparent dimensions indicated (partial draw tubes), may fill more slowly than tubes of the
phenotyping and DAT testing, and blood donor screening for infectious disease such as Syphi-
same size with greater draw volume.
lis Ab, anti-HIV, anti-HTLV, anti-HCV, anti-HBc, and HBsAg. The performance characteristics of
these tubes have not been established for immunohematology testing and infectious disease For tubes subjected to centrifugation to generate plasma or serum for testing, standard
testing in general; therefore, users must validate the use of these tubes for their specific assay- processing conditions do not necessarily completely sediment all cells, whether or not barrier
instrument/reagent system combinations and specimen storage conditions. gel is present. Cell-based metabolism, as well as natural degradation ex vivo, can continue to
affect serum/plasma analyte concentrations/activities after centrifugation. Separated plasma
BD Vacutainer® SST™ Plus Tubes and BD Vacutainer® SST™ Glass Tubes may be used for
samples in particular, will have a gradient of cells and platelets present after centrifugation.
routine blood donor screening and diagnostic testing of serum for infectious disease such
The presence of cells and platelets in the plasma may lead to increased variability and/
as ToRCH, Syphilis Ab, anti-HIV, anti-HTLV, anti-HCV, anti-HBc, and HBsAg. The performance
or instability of certain analytes that are involved in cell/platelet-mediated metabolic
characteristics of these tubes have not been established for infectious disease testing in
processes and/or are present in higher concentrations in cells or platelets. Analytes that
general; therefore, users must validate the use of these tubes for their specific assay-
may be affected include aspartate aminotransferase, glucose, inorganic phosphorus, lactate
instrument/reagent system combinations and specimen storage conditions.
dehydrogenase and potassium. The magnitude of such effects may vary depending on several
BD Vacutainer® CTAD Tubes factors, including whether the plasma is aliquoted or remains in the primary tube, sample
The CTAD tube is used for the collection and transport of specimens for hemostasis testing. agitation, and time. Analyte stability should be evaluated for the storage containers and
The CTAD solution is a mixture of sodium citrate, theophylline, adenosine and dipyridamole. conditions of each laboratory.
The purpose of the additive is to anticoagulate the specimen and to minimize in vitro platelet BD Vacutainer® PST™ Plus Tubes and BD Vacutainer® PST™ Glass Tubes are not
activation. See Precautions, Specimen Collection and Handling Sections. recommended for the collection of samples for blood banking procedures. BD Vacutainer®
BD Vacutainer® Plus Citrate Tubes SST™ Plus Tubes and BD Vacutainer® SST™ Glass Tubes are not recommended for
The tube component is comprised of two plastic tubes assembled together to maintain the immunohematology testing. BD Vacutainer® SST™ Plus Tubes can be used for certain TDM
draw volume and liquid additive. The tube contains buffered sodium citrate additive. All tube assays. Please contact BD Technical Services Department at 1.800.631.0174 for details.
configurations are full draw and utilize BD Hemogard™ Closures. See Limitations of System, Do not use BD Vacutainer® Tubes containing lithium heparin for lithium measurement.
Precautions, Specimen Collection and Handling Sections. The product performance has been For coagulation tests, if patient hematocrit is above 55%, the final citrate concentration
compared to the 4.5mL glass tube for routine coagulation assays on a variety of donor popu- in the specimen should be adjusted.
lations with clinically equivalent results obtained. Note: all studies were performed on donors
with hematocrits between 25 and 55%. Venous blood gas samples collected with BD Vacutainer® Plastic Lithium Heparin tubes
should not be used when testing carboxyhemoglobin (COHb) using the IL GEM 4000
The tube is designed to ensure appropriate fill level. Always allow the tube to fill until the instrument. A clinically significant positive bias with COHb results may occur.
blood ceases to flow. Information on correct tube fill level is provided below.
PRECAUTIONS
Minimum Fill Indicator: 1. Storage of glass tubes containing blood at or below 0ºC may result in tube breakage.
The 360º 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 2. Do not remove conventional rubber stoppers by rolling with thumb. Remove stoppers with
a twist and pull motion.
minimum fill indicator.
3. Do not use tubes or needles if foreign matter is present.
Maximum Fill Level Guidance:
For the 2.7mL tube, if blood meniscus is not visible per the following figure, the tube is 4. The paper label covering the connection of the needle shields will tear when the needle is
opened. Do not use needle if label has been torn before venipuncture.
considered overfilled.
5. CTAD tubes must be protected from artificial and natural light during storage.
For the 1.8mL tube, if blood meniscus is higher than level shown in the figure below, the tube Accumulated light exposure in excess of 12 hours can cause additive inactivation.
is considered overfilled. The meniscus must be at least a distance of 3mm from the bottom
6. Separation of serum or plasma from the cells should take place within 2 hours of collection
edge of the closure as shown in the following figure. to prevent erroneous test results unless conclusive evidence indicates that longer contact
times do not contribute to result error.
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7. D
o not use luer adapters for connection to indwelling catheters/ports; use a Preparation for Specimen Collection
BD Vacutainer® Luer-Lok™ Access Device instead. Be sure the following materials are readily accessible before performing venipuncture:
8. BD Vacutainer® EDTA tubes (Lavender, Pink and Tan Top tubes) and Lithium Heparin 1. See Required Equipment Not Provided for Specimen Collection.
tubes (Green Top tubes) are not recommended for use with Magellan Diagnostics 2. All necessary tubes, identified for size, draw, and additive.
LeadCare® assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or
any other assay employing ASV methodology. 3. Labels for positive patient identification of samples.
Recommended Order of Draw
CAUTION: 1. Tubes for sterile samples.
2. Tubes for coagulation studies (e.g., citrate).
1. Practice Universal Precautions. Use gloves, gowns, eye protection, other personal
protective equipment, and engineering controls to protect from blood splatter, blood 3. BD Vacutainer® SST™ and Serum Tubes.
leakage, and potential exposure to bloodborne pathogens. 4. Tubes with other additives (e.g., heparin, EDTA, fluoride).
2. All glass has the potential for breakage. Examine all glass for potential damage in transit When using a winged blood collection set for venipuncture and a coagulation (citrate) tube is
before use, and take precautionary measures during handling. the first specimen tube to be drawn, a discard tube should be used prior to the first specimen
3. Handle all biologic samples and blood collection “sharps” (lancets, needles, luer adapters, collection. The discard tube must be used to fill the blood collection set tubing’s “dead space”
and blood collection sets) according to the policies and procedures of your facility. with blood. The discard tube does not need to be filled completely. This step will ensure
Obtain appropriate medical attention in the event of any exposure to biologic samples maintenance of the proper blood-additive-ratio of the specimen. The discard tube should
(for example, through a puncture injury), since they may transmit viral hepatitis, HIV be a non additive or coagulation tube. BD Vacutainer® SST™ Tubes and BD Vacutainer®
(AIDS), or other infectious diseases. Utilize any built-inused needle protector, if the Plus Serum Tubes / CAT Tubes contain particulate clot activators and are considered additive
blood collection device provides one. BD does not recommend reshielding used needles. tubes. Therefore, Plus Serum Tubes are not to be used as discard tubes before drawing citrate
However, the policies and procedures of your facility may differ and must always be tubes for coagulation studies.
followed. Prevention of Backflow
4. Discard all blood collection “sharps” in biohazard containers approved for their disposal. Since some evacuated blood collection tubes contain chemical additives, it is important to
avoid possible backflow from the tube, with the possibility of adverse patient reactions.
5. Transferring a sample collected using syringe and needle to a tube is not recommended. To guard against backflow, observe the following precautions:
Additional manipulation of sharps, such as hollow bore needles, increases the potential
for needlestick injury. 1. Place patient’s arm in a downward position.
6. Transferring samples from syringe to an evacuated tube using a non-sharps device should 2. Hold tube with the stopper uppermost.
be performed with caution for the reasons described below. • Depressing the syringe 3. Release tourniquet as soon as blood starts to flow into tube.
plunger during transfer can create a positive pressure, forcefully displacing the stopper 4. Make sure tube additives do not touch stopper or end of the needle during venipuncture.
and sample, causing splatter and potential blood exposure. • Using a syringe for blood Venipuncture Technique and Specimen Collection General Instructions
transfer may also cause over or under filling of tubes, resulting in an incorrect blood-to-
additive ratio and potentially incorrect analytic results. • Evacuated tubes are designed to WEAR GLOVES DURING VENIPUNCTURE AND WHEN HANDLING BLOOD COLLECTION TUBES
draw the volume indicated. Filling is complete when vacuum no longer continues to draw, TO MINIMIZE EXPOSURE HAZARD.
though some tubes may partially fill due to plunger resistance when filled from a syringe. 1. Select tube or tubes appropriate for required specimen. For sterile collections, see the
The laboratory should be consulted regarding the use of these samples. specific instructions noted in the collection device product circular.
7. If blood is collected through an intravenous (I.V.) line, ensure that line has been cleared 2. Assemble needle in holder. Be sure needle is firmly seated to ensure needle does not
of I.V. solution before beginning to fill blood collection tubes. This is critical to avoid unthread during use.
erroneous laboratory data from I.V. fluid contamination. 3. Gently tap tubes containing additives to dislodge any material that may be adhering to
the stopper.
8. Overfilling or under filling of tubes will result in an incorrect blood-to-additive ratio and
may lead to incorrect analytic results or poor product performance. 4. Place tube into holder. Note: Do not puncture stopper.
5. Select site for venipuncture.
9. Endotoxin not controlled. Blood and blood components collected and processed in the
tube are not intended for infusion or introduction into the human body. 6. Apply tourniquet. Prepare venipuncture site with an appropriate antiseptic. DO NOT
PALPATE VENIPUNCTURE AREA AFTER CLEANSING.
STORAGE 7. Place patient’s arm in a downward position.
Store tubes at 4-25ºC (39-77ºF), unless otherwise noted on the package label. All liquid
preservatives and anticoagulants are clear and colorless, except CTAD which is yellow. Do not
use if they are discolored or contain precipitates. Powdered additives such as heparin and
thrombin are white; fluoride and fluoride/oxalate may be pale pink. Do not use if color has
changed. EDTA spray coated additives may have a white to slightly yellow appearance; this
does not affect the performance of the EDTA additive. Do not use tubes after their expiration
date. Tubes expire on the last day of the month and year indicated. 8. R emove needle shield. Perform venipuncture WITH ARM DOWNWARD AND TUBE
SPECIMEN COLLECTION AND HANDLING STOPPER UPPER-MOST.
READ THIS ENTIRE CIRCULAR BEFORE PERFORMING VENIPUNCTURE. 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.
Required Equipment Not Provided for Specimen Collection
10. REMOVE TOURNIQUET AS SOON AS BLOOD APPEARS IN TUBE. DO NOT ALLOW
1. Practice Universal Precautions. Use gloves, eye protection, coats or gowns, and other CONTENTS OF TUBE TO CONTACT THE STOPPER OR END OF THE NEEDLE DURING
appropriate apparel for protection from exposure to bloodborne pathogens or other PROCEDURE.
potentially infectious materials.
2. Any BD Vacutainer® Needle Holders of the standard size may be used with 13 or 16 mm Note: Blood may occasionally leak from the needle sleeve. Practice Universal Precautions to
diameter tubes. A pediatric tube adapter should be used to modify the standard holder to minimize exposure hazard. If no blood flows into tube or if blood ceases to flow before an
fit the 10.25 mm diameter tubes. adequate specimen is collected, the following steps are suggested to complete satisfactory
3. Alcohol swab for cleansing site. If additional tubes requiring sterile collections, such as collection:
blood cultures, are filled from the same venipuncture, use tincture of iodine or suitable a. Push tube forward until tube stopper has been penetrated. If necessary, hold in place to
alternative for cleansing. Follow the laboratory policy for sterile sample collection for site ensure complete vacuum draw.
preparation and tube handling instructions. Do not use alcohol based cleansing materials
when samples are to be used for blood alcohol testing. b. Confirm correct position of needle cannula in vein.
4. Dry, clean disposable gauze. c. REMOVE TUBE AND PLACE NEW TUBE INTO THE HOLDER.
5. Tourniquet. d. If second tube does not draw, remove needle and discard. Repeat procedure from Step 1.
6. Needle disposal container for used needle or needle/holder combination. 11. When first tube has filled to its stated volume and blood flow ceases, remove it from
holder.
Required Equipment Not Provided for Specimen Processing
1. Disposable transfer pipets if direct sampling from the instrument is not used or if speci- 12. Place succeeding tubes in holder, puncturing diaphragm to begin flow. See Recommended
men is stored separately. Order of Draw.
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 Citrate or CTAD tubes 3-4 times. Invert all other filled
to bloodborne pathogens.
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additive tubes 8-10 times. Do not shake. Vigorous mixing may cause foaming or hemolysis. Separated serum or plasma is ready for use. The tubes may be placed directly on the
Insufficient mixing or delayed mixing in serum tubes may result in delayed clotting and instrument carrier or serum/plasma may be pipetted into an analyzer cup. Some instruments
incorrect test results. In tubes with anticoagulants, inadequate mixing may result in platelet can sample directly from a separator tube with the stopper in place. Follow the instrument
clumping, clotting and/or incorrect test results. manufacturer’s instructions.
14. As soon as blood stops flowing in the last tube, remove tube from holder, remove needle ANALYTIC EQUIVALENCY
from vein, applying pressure to puncture site with dry sterile swab until bleeding stops. Evaluations of BD Vacutainer® Tubes have been performed for an array of analytes over a
15. Once clotting has occurred, apply bandage if desired. variety of test methods and time periods. BD Life Sciences - Integrated Diagnostic Solutions
16. After venipuncture, the top of the stopper may contain residual blood. Take proper is available to answer questions regarding these studies. Please contact them to obtain refer-
precautions when handling tubes to avoid contact with this blood. ences and technical reports on these evaluations and any other information regarding the use
17. Dispose of needle and holder per your facility’s policy and guidelines. of BD Vacutainer® Tubes with your instrument/reagent system.
Clotting Instructions TECHNICAL SERVICES
Allow blood to clot thoroughly before centrifugation. The following table gives the recom- BD Life Sciences - Integrated Diagnostic Solutions
mended minimum clotting times for specific tube types or additives. 1 Becton Drive, Franklin Lakes, New Jersey 07417
Minimum Clotting Time Recommendations 1.800.631.0174 eifu.bd.com
PRODUCT TIME (min)
Whenever changing any manufacturer’s blood collection tube type, size, handling, processing
Serum / CAT Tubes 60 or storage condition for a particular laboratory assay, the laboratory personnel should review
BD SST™ Tubes 30 the tube manufacturer’s data and their own data to establish/verify the reference range for a
Thrombin Tubes 5 specific instrument/reagent system. Based on such information, the laboratory can then decide
if a change is appropriate.
Recommended times are based upon an intact clotting process. Patients with abnormal
clotting due to disease, or those receiving anticoagulant therapy require more time for REFERENCES
complete clot formation. CLSI Document GP39-A6:2010. Tubes and Additives for Venous and Capillary Blood Specimen
Collection; approved standard, 6th ed. Wayne, PA: Clinical and Laboratory Standards Institute;
Centrifugation 2010.
Caution: Do not centrifuge glass tubes at forces above 2200 RCF in a horizontal CLSI Document GP41-ED7:2017 Collection of Diagnostic Venous Blood Specimens; approved
head (swinging bucket) centrifuge as breakage may occur. Glass tubes may break if standard, 7th ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.
centrifuged above 1300 RCF in fixed angle centrifuge heads. BD Vacutainer® Plus Tubes
CLSI Document GP44-A4:2010. Procedures for the Handling and Processing of Blood
will withstand up to 10,000 RCF in a balanced centrifuge. Always use appropriate
Specimens for Common Laboratory Tests; approved guideline, 4th ed. Wayne, PA: Clinical and
carriers or inserts. Use of tubes with cracks or chips or excessive centrifugation
speed may cause tube breakage, with release of sample, droplets, and an aerosol Laboratory Standards Institute; 2010.
into the centrifuge bowl. Release of these potentially hazardous materials can be Landt M, Smith CH and Hortin GL. Evaluation of evacuated blood-collection tubes:
avoided by using specially designed sealed containers in which tubes are held during Effects of three types of polymeric separators on therapeutic drug-monitoring specimens.
centrifugation. Centrifuge carriers and inserts should be of the size specific to the tubes Clin Chem 1993; 39:1712-1717.
used. Use of carriers too large or too small for the tube may result in breakage. Dasgupta A, Dean R, Saldana S, Kinnaman G and McLawhon RW. Absorption of therapeutic
RCF is related to centrifuge speed setting (rpm) using the following equation: drugs by barrier gels in serum separator blood collection tubes. Am J Clin Path 1994;
101:456-461.
where “r”, expressed in cm, is the radial distance from the Yawn BP, Loge C and Dale J. Prothombin time, one tube or two? Am J Clin Path 1996;
center of the centrifuge head to the bottom of the tube. 105:794-97.
Gottfried, EL and Adachi, MM. Prothrombin time (PT) and activated partial prothrombin
The following table gives recommended centrifuge RCF and time:
time (APTT) can be performed on the first tube. Am J Clin Path 1997; 107:681-683.
Centrifugation RCF and Time* CLSI Document H21-A5. Collection, Transport, and Processing of Blood Specimens for
PRODUCT RCF (g) TIME (min) Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays;
BD SST™ and BD PST™ Tubes (glass) 1000 – 1300 10 approved guideline, 5th ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
BD SST™ Plus and BD PST™ Plus Tubes - 13mm 1100 – 1300 10 Instructions for Removal of BD Hemogard™ Closure
BD SST™ Plus and BD PST™ Plus Tubes - 16mm 1000 – 1300 10 1. Grasp the BD Vacutainer® Tube with one
hand, placing the thumb under the
BD SST™ Transport Tubes 1100 – 1300 15 BD Hemogard™ Closure. (For added stability,
All Non-gel Tubes ≤ 1300 10 place arm on solid surface). With the other
Citrate Tubes 1500** 15** hand, twist the BD Hemogard™
15 minutes for all gel tubes in a fixed angle centrifuge Closure while simultaneously pushing up with the thumb of the other hand ONLY UNTIL
THE TUBE STOPPER IS LOOSENED.
RCF = Relative Centrifuge Force, g’s
*Use of alternate centrifugation conditions (e.g., higher RCF and shorter spin time) may also 2. Move thumb away before lifting closure. DO NOT use thumb to push closure off tube.
provide acceptable performance; this should be evaluated and validated by the laboratory. Caution: Any glass tube has the potential to crack or break. If the tube contains blood,
an exposure hazard exists. To help prevent injury during closure removal, it is important
**Unless otherwise specified on product labeling. Citrate tubes should be centrifuged at a
speed and time to consistently produce platelet-poor plasma (platelet count <10,000/µL) that the thumb used to push upward on the closure be removed from contact with the tube
per CLSI Guidelines. as soon as the BD Hemogard™ Closure is loosened.
Ensure that tubes are properly seated in the centrifuge carrier. Incomplete seating could 3. Lift closure off tube. In the unlikely event of the plastic shield separating from the rubber
result in separation of the BD Hemogard™ Closures from the tube or extension of the stopper, DO NOT REASSEMBLE CLOSURE. Carefully remove rubber stopper from tube.
tube above the carrier. Tubes extending above the carrier could catch on centrifuge head, Instructions for Reinsertion of BD Hemogard™ Closure
resulting in breakage. Balance tubes to minimize the chance of glass breakage. Match tubes
to tubes of the same fill level, glass tubes to glass, tubes with BD Hemogard™ Closures to 1. Replace closure over tube.
others with the Closure, gel tubes to gel tubes, BD Vacutainer® Plus Tubes with Plus Tubes, 2. Twist and push down firmly until stopper is fully reseated.
and tube size to tube size.
Complete reinsertion of the stopper is necessary for the
Always allow centrifuge to come to a complete stop before attempting to remove tubes. closure to remain securely on the tube during handling.
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.
Caution: Do not remove broken tubes by hand.
See centrifuge instruction manual for disinfection instructions.
Barrier Information
The flow properties of the barrier material are temperature-related. Flow may be impeded
if chilled before or during centrifugation. To optimize flow and prevent heating during
centrifugation, set refrigerated centrifuges to 25ºC (77ºF).
Tubes should not be re-centrifuged once barrier has formed. Barriers are more stable when
tubes are spun in centrifuges with horizontal (swinging bucket) heads than those with fixed
angle heads.
4
SYMBOLS GLOSSARY [L006715(06) 2021-08]
Some symbols listed below may not apply to this product.
US Customers only: For symbol glossary, refer to bd.com/symbols-glossary.
Date of manufacture
Do not stack
Use-by date
Single sterile barrier system
Batch code
Contains or presence of phthalate: combination of bis(2-ethylhexyl) phthalate
Catalogue number (DEHP) and benzyl butyl phthalate (BBP)
Serial number Collect separately
Indicates separate collection for waste of electrical and electronic equipment required.
Sterile
Sterilized using aseptic processing techniques CE marking; Signifies European technical conformity
Sterilized using ethylene oxide
Device for near-patient testing
Sterilized using irradiation
Temperature limit
Internal sequence number
Consult instructions for use or consult electronic instructions for use Meets FCC requirements per 21 CFR Part 15
Caution
UL product certification for US and Canada
Negative control
Positive control
Non-pyrogenic
Becton, Dickinson and Company, 1 Becton Drive, Franklin Lakes, New Jersey 07417-1885 USA
BD, the BD Logo, Eclipse, Hemogard, Luer-Lok, PST, SST, Vacutainer are trademarks of
Becton, Dickinson and Company or its affiliates. All other trademarks are the property of
their respective owners. © 2021 BD. All rights reserved. 2021-08
For U.S. patents that may apply, see bd.com/patents. VDP40445(01)
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