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 is recalling cobas e801 Immunoassay Analyzers due to a software issue that can cause inaccurate results for specific tests. This affects laboratory use and could lead to incorrect medical diagnoses if the device is used without correction.
The software issue causes Pre-Wash tests to produce incorrect signals and results. This affects specific assays like Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG, potentially leading to incorrect medical diagnoses if the device is used without correction.
Laboratories using Roche cobas e801 Immunoassay Analyzers with the specific serial numbers or catalog numbers listed are affected. Medical professionals and lab technicians who rely on these devices for testing are at risk of inaccurate results.
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.
Reach out to Roche Diagnostics Operations, Inc. for specific guidance on the recall and next steps.
The software issue impacts Pre-Wash tests for Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.
Check the serial numbers or catalog numbers listed: UDI-DI 07613336158456 and 04015630946198, or catalog numbers 08454345001 and 07682913001.
Contact Roche Diagnostics Operations, Inc. for specific guidance on the recall and next steps.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1515-2022 — Roche Roche Hello, I own a Roche that is covered by recall Z-1515-2022 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
