Z-0784-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 6, 2019
- Initiation Date
- December 17, 2018
- Termination Date
- April 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70,639 units
Product Description
Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
Reason for Recall
Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
Distribution Pattern
US Nationwide Distribution
Code Information
APP-file version 04.10-101 on the cobas e 602 module.