BEUDAMED
    FDA Recall Open, Classified

    FoundationOne Companion Diagnostic (F1CDx)

    Recall: Z-1891-2025 · Initiated February 15, 2023

    Recall

    Recall Number
    Z-1891-2025
    Event Number
    96804
    Firm
    Foundation Medicine, Inc.
    FEI Number
    3010679023
    Product Code
    PQP
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 15, 2023
    Posted
    May 30, 2025
    Address
    150 2nd St, Cambridge, MA, 02141-2115

    Description

    FoundationOne Companion Diagnostic (F1CDx)

    Reason

    An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.

    Action

    On February 15, 2023, the physician was alerted of the amended report within the physician's portal. Physician was informed original report included an incorrect negative CDx claim on the claims page; the CDx variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. It is requested that any impact to patient care be forwarded to Foundation Medicine.

    Distribution

    US Nationwide distribution in the state of WI.

    Quantity

    1 unit