Vacuette 454322Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K971221); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 8, 2025Class IIOpen, Classified

   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 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 29, 2021Class IITerminated

   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 · Root cause: Process control · Recall details · FDA record ↗

3. Mar 12, 2020Class IITerminated

   Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.

   Z-1714-2020 · Root cause: Process change control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K971221. One submission often covers many models, so check the product and lot details in each record.

• Z-2507-2021 · Aug 20, 2021 · Terminated
  Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
• Z-2154-2012 · Jul 2, 2012 · Terminated
  3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
• Z-1498-06 · Aug 2, 2006 · Terminated
  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 Tube * 454332 * B05
• Z-1331-04 · Jul 27, 2004 · Terminated
  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: 454332, Lot B040404, Exp