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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

Access Vitamin B12 Reagent Recalled for Erroneous Test Results

Agency Publication Date: July 11, 2025
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Summary

Beckman Coulter, Inc. has recalled 10,000 units of Access Vitamin B12 Reagent (Catalog Number 33000) due to complaints of inaccurate test results. Affected reagents from lot 439850 may produce erroneously high or low Vitamin B12 readings. This defect can lead to incorrect medical diagnoses, delayed treatment, or the need for unnecessary repeat testing for patients.

Risk

Inaccurate lab results can cause healthcare providers to misdiagnose Vitamin B12 deficiencies or other conditions, potentially leading to improper medical treatment or a lack of necessary clinical intervention.

What You Should Do

  1. This recall affects Beckman Coulter Access Vitamin B12 Reagent, Catalog Number 33000, specifically identifying with Lot Number 439850 and UDI-DI 15099590224301.
  2. Stop using the recalled product immediately.
  3. Contact Beckman Coulter or your equipment distributor to arrange for the return, replacement, or correction of the affected reagent lots.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

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: Access Vitamin B12 Reagent
Model / REF:
33000
Lot Numbers:
439850
UDI:
15099590224301

Recall Number: Z-2115-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97018
Status: Resolved
Manufacturer: Beckman Coulter, Inc.
Sold By: Clinical laboratories; Hospitals; Healthcare facilities
Manufactured In: United States
Units Affected: 10,000 units

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.