Atellica IM 1600 Analyzer — Class II medical device recall Z-0474-2021
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-11-25, distributed nationwide. Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a
| Recall number | Z-0474-2021 |
|---|---|
| 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 | 2020-10-26 |
| Classified | 2020-11-19 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2024-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, 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 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414002026 |
Product
Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
Reason for recall
Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
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-0474-2021. 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.