Atellica CH 930 Analyzer — Class II medical device recall Z-0861-2021
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2021-01-20, distributed nationwide. Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
| Recall number | Z-0861-2021 |
|---|---|
| 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 | 2020-12-02 |
| Classified | 2021-01-14 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2024-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LT, LV, MX, MY, NL, NO, NZ, OM, PE, PK, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, UA, UY, VN, ZA |
| Quantity | 2,405 units |
| Reason classes | software |
Product
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
Reason for recall
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient 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-0861-2021. 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.