BEUDAMED
    FDA Enforcement Class II Terminated

    FoundationOne CDx test report

    Recall: Z-0535-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0535-2020
    Event ID
    83729
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Foundation Medicine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 4, 2019
    Initiation Date
    August 8, 2019
    Classification Date
    November 22, 2019
    Termination Date
    July 19, 2021
    Address
    150 2nd St, Cambridge, MA, 02141-2115, United States

    Description

    FoundationOne CDx test report

    Reason

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

    Code Info

    Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01

    Distribution

    MA, NC,IN, OH, GA

    Quantity

    8 reports