FDA-Device2022-10-26Class II
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Siemens Healthcare Diagnostics, Inc.
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.
Sold states
Worldwide distribution - US Nationwide.
Affected count
586 US; 694 OUS
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2023Don't want to check this manually?
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