BEUDAMED
    FDA Recall Open, Classified

    FoundationOne CDx (F1CDx), RAL-0003 version 31.0

    Recall: Z-0577-2026 · Initiated November 8, 2022

    Recall

    Recall Number
    Z-0577-2026
    Event Number
    97854
    Firm
    Foundation Medicine, Inc.
    FEI Number
    3010679023
    Product Code
    PQP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 8, 2022
    Posted
    November 21, 2025
    Address
    150 2nd St, Cambridge, MA, 02141-2115

    Description

    FoundationOne CDx (F1CDx), RAL-0003 version 31.0

    Reason

    Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

    Action

    On 08 November 2022, Notification Emails with amended reports were emailed to customers. The Foundation Medicine's Medical Affairs team email alerted its customer to a recently issued amended report [Date of Amended Report] for one of your patients [Patient Order Number]. This Amended Report has been issued to update the report template to include the correct [FoundationOneLiquid CDx/FoundationOneCDx] reporting template, including the associated Claims page. Please note that other aspects of this report may have changed from the previous version to reflect the most up-to-date reporting information. If you have questions about this information, please do not hesitate to call 1-888-988-3639 or email: [email protected]. Please confirm receipt of this email or Foundation Medicine can also follow-up with a phone call.

    Distribution

    US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore.

    Quantity

    59 units (39 US, 20 OUS)