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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.: Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

Agency Publication Date: June 26, 2020
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Affected Products

Product: ADVIA Chemistry Calibrator

Lots: 534177 (including sublots A, B and C) 960742 UDI: (01)00630414223414(10)534177(17)20210930 (01)00630414223414(10)534177A(17)20211031 (01)00630414223414(10)534177B(17)20211231 (01)00630414223414(10)534177C(17)20220131 (01)00630414223414(10)534177D(17)20220331 (01)00630414223414(10)960742(17)20220531

Product: Atellica CH Chemistry Calibrator

534179 (including sublots A, B, C, D and E) 911591 (including sublots A, B, and C) UDI: (01)00630414597492(10)534179(17)20211031 (01)00630414597492(10)534179A(17)20211231 (01)00630414597492(10)534179B(17)20211231 (01)00630414597492(10)534179C(17)20220131 (01)00630414597492(10)534179D(17)20220131 (01)00630414597492(10)534179E(17)20220331 (01)00630414597492(10)911591(17)20220331 (01)00630414597492(10)911591A(17)20220531 (01)00630414597492(10)911591B(17)20220531 (01)00630414597492(10)911591C(17)20220531

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85844
Status: Resolved
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Manufactured In: United States
Units Affected: 2 products (1872 units; 1522 units)

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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.