Z-1515-2022Class II

cobas e801 Immunoassay Analyzer

Name: Z-1515-2022 cobas e801 Immunoassay Analyzer
Creator: Roche Diagnostics Operations, Inc.
Published: 2022-07-14
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2022-07-14 / Open, Classified / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas e801 Immunoassay Analyzer on 2022-07-14. FDA classified it as Class II and gives the reason as "Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1515-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-14
Posted: 2022-08-11
Recalling firm: Roche Diagnostics GmbH
Product: cobas e801 Immunoassay Analyzer
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.
Root cause tag: software
FDA root cause: Software design
Action: The firm distributed an Urgent Medical Device Correction notification via mail by UPS on 07/14/2022. The notice indicates that cobas e801 (Catalog No. 08454345001) and cobas e801 module (Catalog No. 04682913001) are being recalled due to a software issue affecting all analyzers, which may result in impacted signals and sample results of Pre-Wash tests when using Quick Start Mode for the following assays: Anti-HAV 2, Anti-HBc IgM, IGF-1, Myoglobin, Rubella IgG, and Toxo IgG. Customers with affected units are provided workaround instructions to deactivate Quick Start Mode or additional software maintenance with Quick Start Mode still activated. The firm states that the issue will be fixed in the next software version release. Customers are asked to return the attached Faxback form. Any questions are to be directed to Roche Customer Service at 1-800-428-2336.
Quantity in commerce: 965 units
Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, DC & PR.
Product codes and lots: UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1515-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1515-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-11

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)