Greiner Vacuette Blood Collection Tube

510(k) K971221

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK971221	Date2 May 1997Cleared	StatusActive

7 recalls · 1 ongoing · FDA

- Ongoing Z-0408-2026 FDA Class II initiated 8 Aug 2025
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.
- Terminated Z-2507-2021 FDA Class II initiated 20 Aug 2021
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
- Terminated Z-1534-2021 FDA Class II initiated 29 Mar 2021
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.
- Terminated Z-1714-2020 FDA Class II initiated 12 Mar 2020
Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
- Terminated Z-2154-2012 FDA Class II initiated 2 Jul 2012
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
- Terminated Z-1498-06 FDA Unclassified (pre-2012) initiated 2 Aug 2006
Coagulation tubes found with no additive.
- Terminated Z-1331-04 FDA Unclassified (pre-2012) initiated 27 Jul 2004
Coagulation tubes may not have received the proper fill of citrate solution.

1 jurisdiction

United States — FDA 510(k) Active

510(k)