Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay |
| Quantity | 1342 US; 2266 OUS |
| Distribution | Worldwide distribution - US Nationwide. |
| Initiated | 2022-09-19 |
| Classified | 2022-10-20 |
| Recall number | Z-0104-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-0104-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90900/
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