CLASS II Device recall · Reported 18 Dec 2019 · FDA Enforcement Report
Elecsys Anti-HAV IgM assay recalled by Roche Diagnostics Operations
Roche Diagnostics Operations is recalling Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to, distributed nationwide in the US. The recall was initiated on 28 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0669-2020
- FDA event ID
- 84260
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Oct 2019
- FDA classified
- 12 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hepatitis A
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Oct 2019 | Recall initiated by company | |
| 12 Dec 2019 | Classified by FDA | +45 days |
| 18 Dec 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to recalled?
Yes. Roche Diagnostics Operations recalled Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to on 28 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-0669-2020.
Why was it recalled?
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).
Which lots are affected?
Anti-HAV IgM APP-file (version 06.05-101)
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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