medical Class II Updated 2021-01-27

Roche Molecular Systems, Inc. recalls uPath software 1.1 and uPath software 1.1 IVD-INSW, Material

Recalled Product

uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001

Hazard / Issue

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.

Issued by

FDA

Distribution: Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
Lot/Code Info: version 1.1
View official government recall

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