—#177850

Product

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

FDA product code: LOL — Hepatitis A Test (Antibody And Igm Antibody)
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K093955
Affected lot / code info: Anti-HAV IgM APP-file (version 06.05-101)

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2019-10-28
Terminated: 2022-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177850. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.