Recall database

Greiner Bio-One North America, Inc. recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-0571-2026

Greiner Bio-One North America, Inc. recalls Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Cata…

Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat te…

Blood Collection Serum Separators Systems Vials Tubes
Labeling Change Control

Greiner Bio-One North…NCNov 26, 2025

Class IIOngoingZ-0408-2026

Greiner Bio-One North America, Inc. recalls Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%

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.

With Anticoagulant Vacuum Sample Tubes
Under Investigation by firm

Greiner Bio-One North…NCNov 5, 2025