Anti-HAV IgM test System — Class II medical device recall Z-0784-2019
Terminated recall by Roche Diagnostics Corporation, reported 2019-02-06, distributed nationwide. Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrep
| Recall number | Z-0784-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2018-12-17 |
| Classified | 2019-01-29 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2020-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 70,639 units |
| Reason classes | potency |
Product
Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
Reason for recall
Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
Machine access
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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.