Food, drugs, devices › Roche Diagnostics Corporation
Device recall: Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for
FDA enforcement event 81823 is a device recall by Roche Diagnostics Corporation of Indianapolis, IN, initiated 17 Dec 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 10 Apr 2020. Initiation: voluntary: firm initiated. Roche Diagnostics Corporation has 26 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Roche Diagnostics Corporation, Indianapolis, IN.
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."
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0784-2019 | 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… | 70,639 units | Class II | Terminated | 6 Feb 2019 |
Context
Other enforcement events for Roche Diagnostics Corporation
All 26 events for Roche Diagnostics Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Apr 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.