FDA Device recall Z-0105-2023
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay by Siemens Healthcare Diagnostics, citing 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, whi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0105-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-19 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
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.
Identifiers
| code_info | UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0105-2023%22
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