BEUDAMED
    FDA Recall Open, Classified

    FoundationOne Companion Diagnostic (F1CDx)

    Recall: Z-1747-2025 · Initiated April 9, 2025

    Recall

    Recall Number
    Z-1747-2025
    Event Number
    96621
    Firm
    Foundation Medicine, Inc.
    FEI Number
    3010679023
    Product Code
    PQP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 9, 2025
    Posted
    May 12, 2025
    Address
    150 2nd St, Cambridge, MA, 02141-2115

    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.

    Action

    On April 9, 2025 URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters were sent to customers. Asked Customer Immediate Actions: Foundation Medicine respectfully requests your support with the following actions: 1. Review, complete, sign and return the attached business reply form to be returned in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 2. Forward this notice to anyone in your facility that needs to be informed. 3. If there is any impact that requires this notice to be forwarded to another facility, contact that facility and provide them with this letter. 4. Keep a copy of this notice. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Foundation Medicine apologizes for any inconvenience caused by this issue. If any further information or support concerning this issue is needed, please contact Foundation Medicine at any time.

    Distribution

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

    Quantity

    4 units