FDA Devices recall · Reported February 6, 2019
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 clini
Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
Roche Diagnostics Corporation recalled Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys A… - a moderate-severity action.
Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys A… was recalled by Roche Diagnostics Corporation in February 6, 2019. Reason: Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discre…. Check the official notice for the remedy. Verify recall #Z-0784-2019 with the FDA Devices before acting.
The recall
Roche Diagnostics Corporation issued this moderate-severity FDA Devices recall-Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discre….
- Moderate
- severity level
- 71K units
- affected scope
- Class II
- classification
- February 6, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0784-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0784-2019 |
| Date reported | February 6, 2019 |
| Date initiated | December 17, 2018 |
| Recalling firm | Roche Diagnostics Corporation |
| Firm location | Indianapolis, IN |
| Affected scope | 70,639 units |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0784-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026