BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 17, 2025

    Recall

    Recall Number
    Z-2521-2025
    Event Number
    97258
    Firm
    CARIS LIFE SCIENCES
    FEI Number
    3017020141
    Product Code
    PQP
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 17, 2025
    Posted
    September 4, 2025
    Address
    350 W Washington St, Fl 4, Tempe, AZ, 85288-1495

    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

    Action

    On 07/14/2025, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter its customer that inform them that an incorrect CDx report was issued on April 14, 2025 with the wild-type KRAS/NRAS results with VECTIBIX (panitumumab) listed as a therapeutic option. The potential cause of the issue occurred due to two unanticipated events occurring in succession within the operational aspect of the report generation software processes of MI Cancer Seek. These two events in succession resulted in a failing file. Customer was provided with an amended report and instructed to: -Review the report paying careful attention to the amended CDx report with the header "MI Cancer Seek" which changes the wild-type KRAS/NRAS result Detected to wild-type KRAS/NRAS result to Not Detected and the KRAS G12C variant listed in the Other Alterations and Biomarkers Identified section towards the bottom of the page. The new CDx report also includes the banner, Findings did not yield any biomarker results with Companion Diagnostic (CDx) claims . For questions, contact Regulatory Affairs at 351-220-3883 Monday thru Friday 8:00 AM to 5:00 PM Mountain Standard Time or email [email protected]. In addition Caris Customer Support +1-888-979-8669

    Distribution

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

    Quantity

    1