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Roche Molecular Systems, Inc. Recall 86996

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

Roche Molecular Systems, Inc. Recall 86996 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0877-2021
Event ID86996
Event DescriptionuPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Product TypeDevices
DistributionDomestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
Quantity27
Recall ReasonWhen 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.
Device Classification20210127
Device Code Infoversion 1.1
Center Classification Date20210116
Recall Initiation Date20201123
Recalling FirmRoche Molecular Systems, Inc.
Initial Notification Letter
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