BEUDAMED
    FDA Enforcement Class II Ongoing

    FoundationOne Companion Diagnostic (F1CDx)

    Recall: Z-1890-2025 · Reported June 11, 2025

    Enforcement

    Recall Number
    Z-1890-2025
    Event ID
    96802
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Foundation Medicine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2025
    Initiation Date
    June 18, 2024
    Classification Date
    May 30, 2025
    Address
    150 2nd St, N/A, Cambridge, MA, 02141-2115, United States

    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.

    Code Info

    Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure.

    Distribution

    US Nationwide distribution in the state of MI.

    Quantity

    2 units