FDA Device Intelligence
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Tubes, Vacuum Sample, With Anticoagulant

FDA product code GIM · Class 2 · Clinical Chemistry

199
Registered devices
1,965
Adverse events
9
Recalls
39
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-08-08Greiner Bio-One North America, Inc.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 u
2021-08-20Greiner Bio-One North America, Inc.Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
2021-03-29Greiner Bio-One North America, Inc.VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for pro
2020-03-12Greiner Bio-One North America, Inc.Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
2017-02-23StreckComplaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small
2012-07-02Greiner Bio-One North America, Inc.Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
2012-03-05bioMerieux, Inc.The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer Safety Lok Blood Collection Set. The incompatibility i
2006-08-02Greiner Bio-One North America, Inc.Coagulation tubes found with no additive.
2004-07-27Greiner VACUETTE North AmericaCoagulation tubes may not have received the proper fill of citrate solution.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.