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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.: The Access immunoassays are susceptible to biotin interference.

Agency Publication Date: June 28, 2017
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Affected Products

Product: Access Total T3, A34435H, Catalog No. 33830

all lots

Product: Access Thyroglobulin, A34085G, Catalog No. 33860

all lots

Product: Access System-Free T4 Assay, B01902E, Catalog No. 33880

all lots

Product: Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687

all lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77245
Status: Resolved
Manufacturer: Beckman Coulter Inc.
Manufactured In: United States
Units Affected: 4 products (313,158 units total (43,725 units in US); 83,504 units total (23,285 units in US); 1,154,084 units total (167,035 units in US); 249,597 units total (9,388 units in US))

Were You Affected by This Recall?

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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.