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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

Vacuette CAT Serum Separator Tubes Recalled for Missing Gel Separator

Agency Publication Date: November 19, 2025
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Summary

Greiner Bio-One North America, Inc. has recalled approximately 1,980,000 Vacuette 8 ml CAT Serum Separator Clot Activator tubes (Item# 455071P) because some tubes were manufactured without the necessary gel separator. This defect can lead to incorrect blood test results, which may require patients to return to the laboratory for repeat testing. The recalled tubes were distributed to labs and healthcare facilities in 28 U.S. states.

Risk

The missing gel separator can cause inaccurate lab results and delay clinical diagnoses or treatment decisions. In some rare cases, this could lead to incorrect medical treatment based on unstable blood parameters.

What You Should Do

  1. The recalled products are Vacuette 8 ml CAT Serum Separator Clot Activator tubes (Item# 455071P) belonging to Lot# B250437N with UDI-DI code 29120017573061.
  2. Stop using the recalled product immediately.
  3. Contact Greiner Bio-One North America, Inc. or your distributor to arrange for a return, replacement, or correction of the affected tubes.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

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: Vacuette 8 ml CAT Serum Separator Clot Activator
Variants: 16 x 100 mm, 8ml, Standard Stopper
Model / REF:
455071P
Lot Numbers:
B250437N
UDI:
29120017573061

Recall #: Z-0571-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97499
Status: Active
Manufacturer: Greiner Bio-One North America, Inc.
Sold By: Laboratory suppliers; Medical distributors
Manufactured In: United States
Units Affected: 1,980,000
Distributed To: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Wyoming

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.