Recall Z-0784-2019— Roche Diagnostics Corporation
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2018-12-17, terminated 2020-04-10. It names one FDA 510(k) clearance: K093955. Product: 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: Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result..
- Recalling firm
- Roche Diagnostics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-17
- Terminated
- 2020-04-10
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.