Recall Z-0877-2021— Roche Molecular Systems, Inc.

Name: FDA recall Z-0877-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-23

Class II · Terminated

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2020-11-23, terminated 2023-05-22. It names one FDA 510(k) clearance: K140465. Product: uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001. 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: Roche Molecular Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-23
Terminated: 2023-05-22
Firm location: Branchburg, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINERVentana Medical Systems, Inc.·cleared 2014-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.