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.
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Contact the company
📍Recalling firmRoche Molecular Systems, Inc.1080 US Highway 202 S · Branchburg, NJ 08876-3733
“Roche uPath Software 1.1 Recall: Incorrect Measurement Calculations in Split View.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63811-roche-upath-software-1-1-recall-incorrect-measurement-calculations-in. Based on FDA recall #Z-0877-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0877-2021%22&limit=1).
Roche Molecular Systems, Inc. recalled uPath software 1.1 and uPath software 1.1 IVD-INSW on Nov. 23, 2020, according to the FDA. The hazard involves incorrect measurement calculations in Split View mode when slides are scanned 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.
Context
GovInfoNow's records show Roche Molecular Systems, Inc. has had 10 other recalls on record since Oct. 27, 2017. Other recent recalls of similar products include Roche cobas pro integrated solutions recall (Jan. 20, 2026), Merge PACS Workstation Software Inaccurate Measurements - Recall (July 22, 2026), and Intelerad InteleShare Software Recall (Nov. 18, 2025).
How to tell if you have this one
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.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your uPath software version by checking the version number in the software settings or documentation.
Where it went and when
Where it was distributed
Distributed in Maryland and Michigan, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Maryland, Michigan.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
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-0877-2021 (November 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0877-2021 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.