Roche Diagnostics Operations product recalled over hepatitis A risk
- Recall date
- October 28, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Roche Diagnostics Operations, Inc. recalls Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM)…
- Recall number
- Z-0669-2020
- FDA classification
- Class II
- Brand / firm
- Roche Diagnostics Operations, Inc.
- Sold / distributed
- US Nationwide distribution.
Why it was 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).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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