BEUDAMED
    FDA Recall Terminated

    uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001

    Recall: Z-0877-2021 · Initiated November 23, 2020

    Recall

    Recall Number
    Z-0877-2021
    Event Number
    86996
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    NQN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 23, 2020
    Terminated
    May 22, 2023
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001

    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.

    Action

    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.

    Distribution

    Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.

    Quantity

    27