Greiner Bio-One North America, Inc.
Complete recall history across all FDA and CPSC categories — 16 total recalls
Greiner Bio-One North America, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (16)
FDA medical device enforcement actions by Greiner Bio-One North America, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 19, 2025 | Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator ... | Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactu... | Class II |
| Aug 8, 2025 | Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 | Blood collection tubes were manufactured with the label applied too high on ... | Class II |
| May 14, 2024 | VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow... | The firm received reports that some blood collection tubes have experienced i... | Class II |
| Dec 12, 2023 | VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 ... | Tubes have missing additive/anticoagulant resulting in clotting in most cases... | Class II |
| Mar 31, 2023 | greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, no... | Some of the tubes may be incorrectly labeled. | Class II |
| Dec 9, 2021 | greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-... | Some of the blood collection tubes show clotting due to variation of Lithium ... | Class II |
| Aug 20, 2021 | Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75... | Complaint of tubes clotting due to variation of anticoagulant and/or tubes ha... | Class II |
| Aug 13, 2021 | VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged | Blood collection tubes may experience a clotting issue. | Class II |
| Mar 29, 2021 | VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blu... | VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show ... | Class II |
| Aug 28, 2020 | VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P -... | Blood collection tubes experienced an issue with separation and clotting | Class II |
| Mar 12, 2020 | VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot n... | Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsi... | Class II |
| Nov 25, 2019 | VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usag... | The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at th... | Class II |
| Apr 26, 2016 | 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolyt... | The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additiv... | Class II |
| Feb 1, 2013 | VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Coll... | The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (... | Class II |
| Jul 2, 2012 | 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North... | Part of the lot received a lower concentration of citrate solution which may ... | Class II |
| Apr 2, 2012 | Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. ... | : The Quickshield Complete Plus may have a defect (split at the base), which ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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