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

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.

Details from the source

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. Quantity: 586 US; 694 OUS Lot/code info: UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23

UPC codes

00630414006789

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.