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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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).

Recommended Action

Per FDA guidance

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 site, please ensure this Urgent Medical Device Correction (UMDC) is provided to that site. 4. Complete the attached fax form and fax or email it according to the instructions on the form. 5. File this Urgent Medical Device Correction for future use. The UMDC was also posted to the diagnostics.roche.com website. Questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336.