Reported Jan 27, 2021 · Terminated
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Roche Molecular Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 US Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
- Lot codes and dates
- version 1.1
- Amount recalled
- 27
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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