Roche recalls cobas e801 Immunoassay Analyzers with software issue causing inaccurate Pre-Wash test results. Affected units have specific serial numbers and catalog numbers. Consumers should contact Roche for details.
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.
“Roche cobas e801 Immunoassay Analyzer recall: Software issue affects test results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60365-roche-cobas-e801-immunoassay-analyzer-recall-software-issue-affects-test. Based on FDA recall #Z-1515-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1515-2022%22&limit=1).
The FDA announced on July 14, 2022, that Roche Diagnostics Operations, Inc. is recalling cobas e801 Immunoassay Analyzers due to a software issue impacting test results. The agency classified the recall as Class II.
How to tell if you have it
Brand: Roche
Product: cobas e801 Immunoassay Analyzer
UDI-DI: 07613336158456 and 04015630946198
Catalog No.: 08454345001 and 07682913001
All serial numbers
Units affected: 965
The hazard
A software issue results 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.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 2, 2019. Other recent recalls of similar products include Roche cobas pro integrated solutions recall (Jan. 20, 2026), Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include DASH Rapid PCR Instrument Software Issue Recall (Oct. 22, 2025), Siemens Atellica CH A1c_E Test Recall (June 8, 2026), and Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit (June 26, 2026).
How to tell if you have this one
Check the serial numbers or catalog numbers listed in the recall notice: UDI-DI 07613336158456 and 04015630946198, or catalog numbers 08454345001 and 07682913001. All units with these identifiers are affected.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Roche
Reach out to Roche Diagnostics Operations, Inc. for specific guidance on the recall and next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 45 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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 &…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1515-2022 (July 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1515-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.