Vacuette 454334Recalls & reported problems

Summary

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

1 FDA recall record name this device's identifier.

6 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. 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 ↗

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-0408-2026 · Aug 8, 2025 · Open, Classified
  Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
• 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-1714-2020 · Mar 12, 2020 · Terminated
  VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
• 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