uPath software 1.1 and uPath software 1.1 IVD-INSW recall: Software Issue
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Why was uPath software 1.1 and uPath software 1.1 IVD-INSW 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
version 1.1
- Product
- uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 27
- Distribution
- Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
- Recall date
- January 27, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)