Roche recalls uPath software versions 1.1 and 1.1 IVD-INSW due to incorrect measurement calculations when viewing slides in Split View mode at different magnifications.
When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.
Roche is recalling uPath software versions 1.1 and 1.1 IVD-INSW because measurements can be incorrectly calculated when slides are viewed in Split View mode at different magnifications. This could lead to inaccurate results in medical testing.
When creating a measurement tool annotation in the software, the system calculates measurements incorrectly if slides are viewed in Split View mode at different magnifications. This can cause inaccurate results in medical testing, potentially affecting diagnosis.
Users of Roche uPath software version 1.1 for medical diagnostics are affected. Pathologists and lab technicians who use the software for slide analysis are most at risk.
Check for uPath software version 1.1 or 1.1 IVD-INSW with material numbers 08991871001 or 09077332001. The software is used for medical diagnostics and may be installed on computers in labs.
Verify your uPath software version by checking the version number in the software settings or documentation.
The recall is for potential inaccurate measurements in specific viewing conditions, not a direct safety hazard. The software can still be used safely with proper settings.
Check for uPath software version 1.1 or 1.1 IVD-INSW with material numbers 08991871001 or 09077332001.
The recall does not specify a remedy, so users should check their software version and consider updating to a newer version if available.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0877-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0877-2021 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.
