Z-0669-2020Class II

Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus...

Name: Z-0669-2020 Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus...
Creator: Roche Diagnostics Operations, Inc.
Published: 2019-10-28
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-10-28 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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... on 2019-10-28. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0669-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-28
Posted: 2019-12-12
Terminated: 2022-06-28
Recalling firm: Roche Diagnostics GmbH
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
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
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).
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Anti-HAV IgM APP-file (version 06.05-101)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0669-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0669-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-12

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)