Siemens Healthcare Diagnostics, Inc.: Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. 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: 1342 US; 2266 OUS Lot/code info: UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23

UPC codes

00630414287935

Source

Official record: FDA (Device enforcement) ↗

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