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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Greiner BIO-ONE VACUETTE Coagulation Tubes Recalled for Label Error

Agency Publication Date: October 28, 2025
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Summary

Greiner Bio-One North America, Inc. has recalled 504,000 Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2% blood collection tubes. The labels on these tubes were applied too high, causing the printed fill level mark to be shifted upward. This defect can lead to laboratory staff incorrectly rejecting blood samples as underfilled, which then requires patients to undergo repeat blood collections.

Risk

Because the fill mark is incorrectly placed, medical professionals may believe a tube is underfilled even when it contains the correct volume of blood. This results in unnecessary sample rejection and the need for additional, avoidable blood draws for the patient.

What You Should Do

  1. This recall affects Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2% tubes (REF 454322) with lot number B250139Q, expiration date 01/09/2026, and UDI-DIs 29120017574488 (Rack) or 39120017574485 (Case).
  2. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  3. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%
Model / REF:
454322
Lot Numbers:
B250139Q (Exp 01/09/2026)
UDI:
29120017574488
39120017574485

Quantity: 504,000 units affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97457
Status: Active
Manufacturer: Greiner Bio-One North America, Inc.
Sold By: Medical distributors; Laboratories; Hospitals
Manufactured In: United States
Units Affected: 504,000
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.