Roche Molecular Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0877-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 23, 2020

Date Posted: January 27, 2021

Recall Number: Z-0877-2021

Event ID: 86996

Reason for Recall:

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.

Status: Terminated

Product Quantity: 27

Code Information:

version 1.1

Distribution Pattern:

Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated