medical Class II Updated 2019-12-18

Roche Diagnostics Operations, Inc. recalls Elecsys Anti-HAV IgM assay-for the in vitro qualitative dete

Recalled Product

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


Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Anti-HAV IgM APP-file (version 06.05-101)
View official government recall

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