FDANovember 23, 2020device
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
roche molecular systemsrocheroche molecular
UPCs
0899187100109077332001
Recall history
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