IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER — Class II medical device recall Z-1675-2021
Ongoing recall by Roche Diagnostics Operations, Inc., reported 2021-06-02, distributed nationwide. Roche received several complaints regarding increased control recovery and discrepant elevated results for the
| Recall number | Z-1675-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2021-04-26 |
| Classified | 2021-05-24 |
| Reported by FDA | 2021-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 20,468 kits |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 04015630918904 |
| Model numbers | 03183696122 |
Product
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
Reason for recall
Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.
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-1675-2021. 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.