FDA recall Z-0669-2020

Roche Diagnostics Operations, Inc. · Class II · device

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

Reason for recall

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).

Distribution

US Nationwide distribution.

Key facts

Status: Terminated
Initiation date: 2019-10-28
Report date: 2019-12-18
Termination date: 2022-06-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2020