BEUDAMED
    FDA Recall Terminated

    FoundationOne CDx test report

    Recall: Z-0535-2020 · Initiated August 8, 2019

    Recall

    Recall Number
    Z-0535-2020
    Event Number
    83729
    Firm
    Foundation Medicine, Inc.
    FEI Number
    3010679023
    Product Code
    PQP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 8, 2019
    Terminated
    July 19, 2021
    Address
    150 2nd St, Cambridge, MA, 02141-2115

    Description

    FoundationOne CDx test report

    Reason

    Identified potential false positive MSI-H on the test reports provided to the physicians.

    Action

    Firm informed the physicians via phone stating: 1. They had recently received may have an incorrect MSI-H result which could be erroneous due to a possible false positive and to not use the MSI analyte to prescribe treatment. 2. The prescribing physicians were also told that an amended report designating MSI as undetermined would be issued immediately. 3. The physicians were asked if any treatment plan using the MSI result had been started and all confirmed that no treatment plan utilizing the MSI analyte had been used. 4. They were also informed of the availability of FMI Medical Affairs staff physicians to provide additional information or answer any follow questions that they may have.

    Distribution

    MA, NC,IN, OH, GA

    Quantity

    8 reports