Recall Z-0669-2020 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Roche Diagnostics Operations, Inc.
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
| Date | Oct 28, 2019 |
| Status | Terminated |
| 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). |
| Root cause | Employee error |
| Action | Roche notified consignees via Urgent Medical Device Correction TP-00811 mailed via UPS Ground (receipt required) on 10/28/19. Letter states reason for recall, health risk and action to take: Consignee Instructions: 1. Follow the instructions provided in the Actions to be Taken by Customers/Users Currently Using APP-file Version 06.05-101 section of this communication. 2. Confirm your cobas e 801 module is using the updated APP-file xx.xx-102 (version 102). If it is not, immediately update to APP-file xx.xx-102 (version 102). 3. If your facility has distributed the affected product to another |
| Quantity | 712 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 |