Device product
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Z-0105-2023
Product summary
- Event
- Event 90900
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 586 US; 694 OUS
- Official record key
device-enforcement:Z-0105-2023
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: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23
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.