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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Recalled October 26, 2022 · FDA recall Z-0105-2023 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
586 US; 694 OUS
Sold at
Worldwide distribution - US Nationwide.
Description
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.
Product
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →