Device product
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Z-0104-2023
Product summary
- Event
- Event 90900
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1342 US; 2266 OUS
- Official record key
device-enforcement:Z-0104-2023
Official wording
Reason: 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.
Code information: UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Unknown
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.