BEUDAMED
    FDA Enforcement Class II Ongoing

    MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.

    Recall: Z-2521-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2521-2025
    Event ID
    97258
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CARIS LIFE SCIENCES
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2025
    Initiation Date
    June 17, 2025
    Classification Date
    September 4, 2025
    Address
    350 W Washington St Fl 4, N/A, Tempe, AZ, 85288-1495, United States

    Description

    MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.

    Reason

    Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

    Code Info

    Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF

    Distribution

    U.S. Nationwide distribution in the state of NY.

    Quantity

    1