Atellica CH 930 Analyzer with Software version: V1 — Class II medical device recall Z-0449-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-01-12, distributed nationwide. (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel A
| Recall number | Z-0449-2022 |
|---|---|
| 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 | 2021-11-18 |
| Classified | 2022-01-03 |
| Reported by FDA | 2022-01-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,980 units |
| Reason classes | potency, specification failure, software |
| UPC / GTIN / UDI-DI | 00630414002163 |
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 for recall
(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
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-0449-2022. 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.