FDA-Device2019-12-18Class II
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
Roche Diagnostics Operations, Inc.
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).
Sold states
US Nationwide distribution.
Affected count
712 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2020Don't want to check this manually?
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