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Greiner Bio-One North America Recalls
16 recalls on record · July 11, 2012 to November 26, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 26, 2025Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Desc
Hazard: 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 testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.
November 5, 2025Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Hazard: 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.
July 24, 2024Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Hazard: The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.
January 24, 2024Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Hazard: Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.
May 24, 2023Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in
Hazard: Some of the tubes may be incorrectly labeled.
January 26, 2022Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs
Hazard: Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
October 6, 2021Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Hazard: Blood collection tubes may experience a clotting issue.
September 29, 2021Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ri
Hazard: Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
May 12, 2021Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
Hazard: 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.
October 7, 2020Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transp
Hazard: Blood collection tubes experienced an issue with separation and clotting
April 22, 2020Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Hazard: Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
January 29, 2020Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are
Hazard: The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.
June 15, 2016Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolyti
Hazard: The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.
February 27, 2013Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage:
Hazard: The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
August 15, 2012Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe,
Hazard: Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
July 11, 2012Medical DevicesFDA
Greiner Bio-One North America, Inc. recalls Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intend
Hazard: : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.