Atellica CH 930 Analyzer — Class II medical device recall Z-2026-2021
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2021-07-14, distributed nationwide. Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction
| Recall number | Z-2026-2021 |
|---|---|
| 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 | 2021-05-13 |
| Classified | 2021-07-07 |
| Reported by FDA | 2021-07-14 |
| 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, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LT, LV, MA, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, UA, UY, VN, ZA |
| Reason classes | potency, packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00630414002163 |
Product
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Reason for recall
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
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-2026-2021. 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.