FDA Device recall Z-0449-2022
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro d…
- FDA Device
- Class II
- ongoing
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro d… by Siemens Healthcare Diagnostics, citing (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magn….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0449-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-18 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
Reason
(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results
Identifiers
| code_info | Software version: V1.25.1 and lower. UDI: 00630414002163 |
|---|
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-0449-2022%22
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