Atellica CH Lithium_2 — Class II medical device recall Z-0104-2023
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-10-26, distributed nationwide. Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there
| Recall number | Z-0104-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2022-09-19 |
| Classified | 2022-10-20 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00630414287935 |
| Lot numbers | 110238, 110302, 120017 |
| Expiration dates | 2022-10-18, 2022-12-13, 2023-04-18 |
Product
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0104-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.