FDA recall Z-0105-2023

Product

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

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide.

Key facts

Status

Ongoing

Initiation date

2022-09-19

Report date

2022-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2023