Atellica IM 1600 Analyzer — Class II medical device recall Z-1253-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-06-15, distributed nationwide. Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous tot
| Recall number | Z-1253-2022 |
|---|---|
| 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 | 2022-04-13 |
| Classified | 2022-06-09 |
| Reported by FDA | 2022-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BD, BE, BR, BS, CH, CL, CN, CZ, DE, DK, EC, EG, ES, FR, GB, GR, HR, IL, IN, IT, JP, KR, LV, MX, MY, NL, PE, PH, PT, PY, RO, RS, SA, SE, SG, SK, TR, TW, VN |
| Quantity | 2,321 |
| UPC / GTIN / UDI-DI | 00630414002026 |
Product
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
Reason for recall
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 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-1253-2022. 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.