BEUDAMED
    FDA Recall Open, Classified

    FoundationOne Companion Diagnostic (F1CDx)

    Recall: Z-1890-2025 · Initiated June 18, 2024

    Recall

    Recall Number
    Z-1890-2025
    Event Number
    96802
    Firm
    Foundation Medicine, Inc.
    FEI Number
    3010679023
    Product Code
    PQP
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 18, 2024
    Posted
    May 30, 2025
    Address
    150 2nd St, Cambridge, MA, 02141-2115

    Description

    FoundationOne Companion Diagnostic (F1CDx)

    Reason

    Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.

    Action

    On June 18, 2024, amended reports were sent to customers. It was to alert customers to an amended report that was recently released on 6/18/24. The new report replaces the report of 2/11/24. Additional contact was made on June 20, 2024 to communicate the error and provide the updated report to the customer.

    Distribution

    US Nationwide distribution in the state of MI.

    Quantity

    2 units