Atellica IM 1300 Analyzer — Class II medical device recall Z-0204-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2019-10-30, distributed nationwide. Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer
| Recall number | Z-0204-2020 |
|---|---|
| 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 | 2019-08-15 |
| Classified | 2019-10-24 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2022-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BD, BE, BR, CH, CN, CO, DE, DO, ES, FI, FR, GB, GR, IT, JP, KR, LV, MX, NL, SG, TH, VN |
| UPC / GTIN / UDI-DI | 00630414007960 |
Product
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Reason for recall
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
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-0204-2020. 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.