Company: Roche Molecular Systems, Inc.
Date of Enforcement Report: 1/27/2021
Class II
PRODUCT
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Recall Number: Z-0877-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc. on 11/23/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
27
DISTRIBUTION
U.S. Nationwide and International