Z-0877-2021 Class II Terminated
FDA device recall Z-0877-2021 was initiated by Roche Molecular Systems, Inc. on November 23, 2020 and is designated Class II. 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 m… The recall status is terminated (terminated May 22, 2023). Affected quantity: 27.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- November 23, 2020
- Termination Date
- May 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27
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.
Distribution Pattern
Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
Code Information
version 1.1