uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Reported: January 27, 2021 Initiated: November 23, 2020 #Z-0877-2021
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.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 27
- Distribution
- Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001. Recalled by Roche Molecular Systems, Inc.. Units affected: 27.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2021. Severity: Moderate. Recall number: Z-0877-2021.
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