FDADecember 17, 2018device
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). ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
11820591160
Recall history
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