FDA-Device2021-01-27Class II
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Roche Molecular Systems, Inc.
Hazard
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.
Sold states
Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
Affected count
27
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0877-2021Don't want to check this manually?
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