Class 2 Device Recall Elecsys AntiHAV IgM

• Date Initiated by Firm: October 28, 2019
• Create Date: December 12, 2019
• Recall Status: Terminated on June 28, 2022
• Recall Number: Z-0669-2020
• Recall Event ID: 84260
• 510(K)Number: K093955
• Product Classification: Hepatitis a test (antibody and igm antibody) - Product Code LOL
• 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
• Code Information: Anti-HAV IgM APP-file (version 06.05-101)
• FEI Number: 1823260
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Roche Customer Support Center; 800-428-2336
• Manufacturer Reason for Recall: 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).
• FDA Determined 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 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.
• Quantity in Commerce: 712 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LOL