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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.: Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

Agency Publication Date: October 20, 2022
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Affected Products

Product: Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay

UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23

Product: Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay

UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90900
Status: Active
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Manufactured In: United States
Units Affected: 2 products (1342 US; 2266 OUS; 586 US; 694 OUS)

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.