Tubes, Vacuum Sample, With Anticoagulant
Clinical Chemistry · 21 CFR 862.1675
Recent MDR events
1,965 adverse event reports on file
- VACUETTE® TUBE 3 ml 9NC Coagulation sodium citrate 3,2% 13x75Jul 30, 2026MalfunctionGreiner Bio-one Na Inc.1125230-2026-00017
- BD Vacutainer® K2 EDTA (K2E) 7.2mg Blood Collection TubesJul 29, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00670
- BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection TubesJul 29, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00668
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection TubesJul 29, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00669
- BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection TubesJul 29, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00667
- BD Vacutainer® K2 EDTA (K2E) 7.2mg Blood Collection TubesJul 28, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00661
- BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection TubesJul 27, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00648
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection TubesJul 27, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00650
- See H11Jul 27, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00649
- BD MiniDraw¿ H&H Capillary Blood Collection TubeJul 27, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)2618282-2026-00120
Event type breakdown
Recalls
9 recall events for this product code
- Greiner Bio-One North America, Inc.Open, ClassifiedOct 28, 2025
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
Z-0408-2026 · View FDA record ↗ - Greiner Bio-One North America, Inc.TerminatedMay 6, 2021
VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in c
VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.
Z-1534-2021 · View FDA record ↗ - StreckOpen, ClassifiedMar 8, 2017
Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box R
Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.
Z-1684-2017 · View FDA record ↗ - Greiner Bio-One North America, Inc.TerminatedAug 7, 2012
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334,
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
Z-2154-2012 · View FDA record ↗ - bioMerieux, Inc.TerminatedMar 30, 2012
BacT/ALERT Blood Collection Adapter
The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer Safety Lok Blood Collection Set. The incompatibility is the blood collection set needle backing out of the adapter cap that results in an exposed sheathed needle that may lead to an accidental needlestick.
Z-1336-2012 · View FDA record ↗ - Greiner Bio-One North America, Inc.TerminatedSep 13, 2006
Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich
Coagulation tubes found with no additive.
Z-1498-06 · View FDA record ↗ - Greiner VACUETTE North AmericaTerminatedAug 10, 2004
Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 4543
Coagulation tubes may not have received the proper fill of citrate solution.
Z-1331-04 · View FDA record ↗ - Greiner Bio-One North America, Inc.TerminatedUnknown
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
Z-1714-2020 · View FDA record ↗ - Greiner Bio-One North America, Inc.TerminatedUnknown
Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
Z-2507-2021 · View FDA record ↗
Registered firms
87 firms currently registered for this product code
Companhia Brasileira De Esterilizacao
Jarinu Sao Paulo, BR
Km Medical
North York Ontario, CA
Mainline Medical Dental Supply
North York Ontario, CA
Innopex Limited
Toronto Ontario, CA
Deroyal Industries, Inc.
POWELL, TN, US
Cardinal Health 200, Llc
Waukegan, IL, US
Maya Medical Top Trade Ltd.
Tsofit Central, IL
Becton, Dickinson & Co.
BROKEN BOW, NE, US
Greiner Bio-one Gmbh
KREMSMUENSTER Oberosterreich, AT
Caltag Medsystems Ltd
Buckingham Buckinghamshire, GB
Porex Corporation
FAIRBURN, GA, US
Sterigenics U.s., Llc
Charlotte, NC, US
Cardinal Health
Norfolk, NE, US
Sterigenics U.s., Llc
Haw River, NC, US
Streck Llc
La Vista, NE, US
Cardinal Health
Hazelwood, MO, US
Cbr Enterprise Limited
Hong Kong, HK
Sterigenics U.s., Llc
Ontario, CA, US
510(k) clearances
39 clearances for this product code
- Becton, Dickinson and CompanyOct 31, 2024
K240455 · BD Vacutainer® Citrate Blood Collection Tubes
- Becton, Dickinson and CompanyNov 27, 2023
K230493 · BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
- Becton, Dickinson and CompanyAug 25, 2023
K213670 · BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
- Caltag Medsystems, Ltd.Jun 22, 2017
K162723 · TransFix/EDTA Vacuum Blood Collection Tubes
- StreckJul 31, 2008
K080552 · CYTO-CHEX BCT
- Drew Scientific , Ltd.Sep 18, 2001
K012152 · DS30 HCY BLOOD COLLECTION TUBES
- Becton Dickinson Vacutainer SystemsJun 17, 1997
K971449 · VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
- Greiner America, Inc.May 2, 1997
K971221 · GREINER VACUETTE BLOOD COLLECTION TUBE