Z-0784-2019Class II

Anti-HAV IgM test System, Material No. 11820591160

Name: Z-0784-2019 Anti-HAV IgM test System, Material No. 11820591160
Creator: Roche Diagnostics Corporation
Published: 2018-12-17
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2018-12-17 / Terminated / root cause: software

FDA source

Roche Diagnostics Corporation began a recall of 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... on 2018-12-17. FDA classified it as Class II and gives the reason as "Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0784-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-17
Posted: 2019-01-29
Terminated: 2020-04-10
Recalling firm: Roche Diagnostics GmbH
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.
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
Reason for recall: 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 tag: software
FDA 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 [email protected]. - 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 in commerce: 70,639 units
Distribution: US Nationwide Distribution
Product codes and lots: APP-file version 04.10-101 on the cobas e 602 module.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0784-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0784-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-29

Product code LOL

K093955Class IIAnti-Hav IgmRoche Diagnostics / cleared 2010-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)