Recall Z-0877-2021

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.

FDA-determined cause: Software design

Action taken

On November 23, 2020, the firm initiated its recall. The firm distributed Urgent Medical Device Correction letters to affected customers using uPath software version 1.1 IVD. Until uPath Enterprise software version 1.1.1 patch is installed, customers using uPath Enterprise software version 1.1 should not analyze slides with different scan magnifications in Split View. In order to reduce the risk of this issue impacting patient care, customers should follow their local procedures and policies regarding retrospective re-review of cases. In particular, it is recommended that cases involving tumor measurements (e.g., melanoma, etc.) be considered for re-review, especially if the original diagnosis included a reported measurement (e.g., Breslow depth in melanoma, etc.). Pathologists need to assess the risk of this measurement error in the context of local pathology reporting processes and clinical decision making. Re-review should be limited to the following conditions, all of which are required for the issue to occur: 1. Slides were viewed in uPath Enterprise software version 1.1, 2. The tumor measurement was done in the Split View viewing mode, and 3. The slides within the Split View viewing mode were scanned at two different magnifications. Only under these conditions is a re-review and repeat tumor measurement recommended.