Siemens Atellica CH 930 Analyzer — Class II medical device recall Z-0148-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-10-23, distributed nationwide. Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
| Recall number | Z-0148-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2019-07-30 |
| Classified | 2019-10-16 |
| Reported by FDA | 2019-10-23 |
| Terminated | 2022-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HU, ID, IE, IL, IN, IR, IT, JP, KR, KW, LV, MX, MY, NG, NL, NO, PH, PK, PL, PT, QA, RO, SA, SE, SG, SK, TH, TR, TW, UY, VN, ZA |
| Quantity | 1,125 units |
| Reason classes | software |
Product
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Reason for recall
Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
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-0148-2020. 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.