Roche recalls Omni S Analyzer AutoQC Module Complete (catalogs 3313522001, 3313522692) due to software failure preventing scheduled quality control tests. This may affect test accuracy in critical care labs.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Roche is recalling the AutoQC Module Complete for the Omni S Analyzer because its software won't activate scheduled quality control tests. This could lead to inaccurate test results in critical care settings if not fixed.
The software that starts scheduled AutoQC measurements fails to activate. This means quality control tests aren't run on time, which could lead to inaccurate test results if the analyzer isn't properly calibrated.
Lab users with the Omni S Analyzer and the specified AutoQC Module Complete (catalog numbers 3313522001 or 3313522692) are affected. Critical care labs using this combination are most at risk.
Check for the AutoQC Module Complete with catalog numbers 3313522001 or 3313522692. The product is part of the Roche Omni S Analyzer system for critical care testing.
Identify the catalog number on the AutoQC Module Complete to confirm if it's 3313522001 or 3313522692.
The software responsible for starting scheduled AutoQC measurements will not activate, which could lead to inaccurate test results if quality control tests aren't run on time.
The recall record does not specify a remedy, so no action is required beyond checking the catalog number.
The product is safe to use as long as the software issue is addressed by the manufacturer, but the recall indicates a potential risk for inaccurate test results.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1613-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1613-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
