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 hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.

Recall number

Z-0784-2019

Recalling firm

Roche Diagnostics Corporation

Product

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 hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.

Status

Terminated

Initiated

2018-12-17

Posted

not on file

Terminated

2020-04-10

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 information. 2. Review the APP-file version downloaded for the Anti-HAV IgM application. The most current APP-file version is (05.30 - 402). Download this version of the APP-file for the Anti-HAV IgM assay. You can determine the APP-file version for Anti-HAV IgM currently installed on your cobas e 602 module by going to Utility > Application > Select Anti-HAV IgM test > Analyze tab, bottom right corner of the screen. **Actions Required** - Follow the instructions provided in the Actions to be Taken by Customers/Users Currently Using APP-file Version 04.10 - 101 - Confirm your cobas e 602 module is using APP-file 05.30 - 402. If it is not, immediately update to APP-file 05.30 - 402. - Complete all sections of the fax form (TP-00518) and fax it to 1-855-207-2758 or email it to 6189roche@stericycle.com. - File the Urgent Medical Device Correction for future use. Customers with questions please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336

Quantity

70,639 units

Distribution

US Nationwide Distribution

Lot, serial or model codes

APP-file version 04.10-101 on the cobas e 602 module.

510(k) numbers

["K093955"]

PMA numbers

not on file

Product code

LOL

Firm FEI

1823260

Firm city

Indianapolis

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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