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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

Siemens Healthcare Diagnostics, Inc: Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.

Agency Publication Date: November 3, 2021
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Affected Products

Product: Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861

Lot # 44989001 - Exp. Date 2021-10-07, UDI # (01)00630414611846(10)44989001(17)20211007; Lot # 60407003 - Exp. Date 2021-03-22, UDI # (01)00630414611846(10)60407003(17)20211112.

Lot Numbers:
44989001
60407003
Product: ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866

Lot # 44990001, Exp. Date 2021-10-07, UDI # (01)00630414611747(10)44990001(17)20211007. Lot # 60408003, Exp. Date 2021-11-12, UDI # (01)00630414611747(10)60408003(17)20211112.

Lot Numbers:
44990001
60408003

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88768
Status: Resolved
Manufacturer: Siemens Healthcare Diagnostics, Inc
Manufactured In: United States
Units Affected: 2 products (149 kits; 261 kits)

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.