FDAFDA · Food and drugs·Recall number Z-0669-2020
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
Published December 18, 2019 · Recall initiated: October 28, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- Anti-HAV IgM APP-file (version 06.05-101)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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