Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical… — Class II medical device recall Z-1586-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-05-09, distributed in FL. When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion fac
| Recall number | Z-1586-2018 |
|---|---|
| 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 | 2018-02-26 |
| Classified | 2018-05-01 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2020-05-12 |
| Distributed | FL |
| Countries outside the US | DE, ES, FR, GB, SE |
| UPC / GTIN / UDI-DI | 00630414007960 |
Product
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Reason for recall
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
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-1586-2018. 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.