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
Z-0669-2020
Product summary
- Event
- Event 84260
- Status
- Terminated
- Classification
- Class II
- Quantity
- 712 units
- Official record key
device-enforcement:Z-0669-2020
Official wording
Reason: 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).
Code information: Anti-HAV IgM APP-file (version 06.05-101)
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Device software or design
software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous