BEUDAMED
    FDA Enforcement Class II Ongoing

    FoundationOne Companion Diagnostic (F1CDx)

    Recall: Z-1747-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1747-2025
    Event ID
    96621
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Foundation Medicine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2025
    Initiation Date
    April 9, 2025
    Classification Date
    May 12, 2025
    Address
    150 2nd St, Cambridge, MA, 02141-2115, United States

    Description

    FoundationOne Companion Diagnostic (F1CDx)

    Reason

    Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.

    Code Info

    ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.

    Distribution

    Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.

    Quantity

    4 units