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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0877-2021 |
| Event ID | 86996 |
| Event Description | uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 |
| Product Type | Devices |
| Distribution | Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore. |
| Quantity | 27 |
| Recall Reason | 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. |
| Device Classification | 20210127 |
| Device Code Info | version 1.1 |
| Center Classification Date | 20210116 |
| Recall Initiation Date | 20201123 |
| Recalling Firm | Roche Molecular Systems, Inc. |
| Initial Notification | Letter |
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