Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay — recall Z-0105-2023
U.S. FDA — Device Enforcement · United States · 2022-09-19 · Class II
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Reported risk: 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.
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