FDA Device recall Z-0931-2022
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
- FDA Device
- Class II
- ongoing
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0931-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-09 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Reason
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Identifiers
| code_info | UDI: 00630414287935; Lot Numbers: 110108 110185 110238 110302 |
|---|
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-0931-2022%22
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