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FDAOctober 28, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

07026773190

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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