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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

Beckman Coulter Inc.: NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.; NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.

Agency Publication Date: October 24, 2019
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Affected Products

Product: Beckman Coulter Lipase, REF OSR6130 and OSR6230.

All lots

Product: Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.

All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83583
Status: Resolved
Manufacturer: Beckman Coulter Inc.
Manufactured In: United States
Units Affected: 2 products (20,926 units; 19,834 uits)

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.

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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 · 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.