FDA Device recall Z-0928-2022
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
- FDA Device
- Class II
- ongoing
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 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-0928-2022 |
| 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 Calcium_2 (CA_2), Siemens Material Number 11097644
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: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526 |
|---|
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-0928-2022%22
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