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Greiner Bio-One North America, Inc. FDA Recalls

9 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product DescClass IIAug 19, 2025Some of the Vacuette¿ CAT Serum Separator Clot Activator tub
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322Class IIAug 8, 2025Blood collection tubes were manufactured with the label app
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridgedClass IIMay 14, 2024The firm received reports that some blood collection tubes h
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.Class IIDec 12, 2023Tubes have missing additive/anticoagulant resulting in clott
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in Class IIMar 31, 2023Some of the tubes may be incorrectly labeled.
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcsClass IIDec 9, 2021Some of the blood collection tubes show clotting due to vari
Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-riClass IIAug 20, 2021Complaint of tubes clotting due to variation of anticoagulan
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridgedClass IIAug 13, 2021Blood collection tubes may experience a clotting issue.
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridgedClass IIMar 29, 2021VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citra

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