Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0877-2021 — uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001

U.S. FDA — Device Enforcement · United States · 2020-11-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0877-2021
Date of alert
2020-11-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Molecular Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08991871001
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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