Z-0669-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- October 28, 2019
- Termination Date
- June 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 712 units
Product Description
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 Pattern
US Nationwide distribution.
Code Information
Anti-HAV IgM APP-file (version 06.05-101)