Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of… — Class II medical device recall Z-0669-2020
Terminated recall by Roche Diagnostics Operations, Inc., reported 2019-12-18, distributed nationwide. Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area
| Recall number | Z-0669-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-10-28 |
| Classified | 2019-12-12 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2022-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 712 units |
| Reason classes | software |
| Model numbers | 07026773190 |
Product
Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
Reason for recall
Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).
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-0669-2020. 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.