Recall Z-0784-2019 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Roche Diagnostics Corporation
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 h
| Date | Dec 17, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Software Design Change |
| Action | Roche issued URGENT MEDICAL DEVICE CORRECTION notices and Fax Forms dated 12/17/2018 to customers via UPS courier service. **Actions to be Taken by Customers/Users Currently Using APP-file Version 04.10 - 101** 1. If your LIS host stores the interpretation and COI information for Anti-HAV IgM, all COI results in the gray zone of 0.90 1.10 should be reviewed. Implement the following action for all gray zone results: If discrepant interpretation of results is suspected, re-testing may be advisable in concordance with the recommendations in the assay method sheet and relevant clinical infor |
| Quantity | 70,639 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093955 | ANTI-HAV IGM Roche Diagnostics, Jun 22, 2010 |