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