Lower riskMedical device recall · FDA · Published August 8, 2025
Greiner Bio-One VACUETTE 2ml Coagulation Tubes: Incorrect Fill Level Label May Cause
Greiner Bio-One recalls 2ml coagulation tubes with misaligned fill level labels that may cause sample rejection and repeat blood draws. Affected lots: B250139Q, expiring 01/09/2026.
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.
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Contact the company
📍Recalling firmGreiner Bio-One North America, Inc.4238 Capital Dr · Monroe, NC 28110-7681
“Greiner Bio-One VACUETTE 2ml Coagulation Tubes: Incorrect Fill Level Label May Cause.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51660-greiner-bio-one-vacuette-2ml-coagulation-tubes-incorrect-fill-level. Based on FDA recall #Z-0408-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0408-2026%22&limit=1).
The FDA announced on 2025-08-08 that Greiner Bio-One North America, Inc. is recalling Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate tubes due to a manufacturing defect. The hazard involves misaligned fill level marks that could cause unnecessary sample rejection and repeat collections.
According to the FDA, blood collection tubes were manufactured with labels applied too high, shifting the printed fill level mark upward. This defect could result in unnecessary sample rejection and repeat collections.
Context
GovInfoNow's records show Greiner Bio-One North America, Inc. has 11 other recalls on record since 2019-11-25. Other recent recalls of similar products include Vacuette 8ml CAT Serum Separator Clot Activator Tubes May Cause Incorrect Test Results (2025-08-19), Greiner Bio-One VACUETTE Tube Recall: Clotting Issues May Delay Treatment (2024-05-14), and Greiner Bio-One VACUETTE Tube 4ml FX: Clotting Risk in Blood Tests (2023-12-12).
How to tell if you have this one
Check for the model 'VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%' with lot number B250139Q. These tubes were sold with expiration date 01/09/2026.
Brand
Greiner Bio-One
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Tube Label
Look for the lot number B250139Q on the tube's packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0408-2026 (August 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0408-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.