BEUDAMED
    FDA Recall Terminated

    FoundationOne CDx Test Results

    Recall: Z-0649-2019 · Initiated October 31, 2018

    Recall

    Recall Number
    Z-0649-2019
    Event Number
    81614
    Firm
    Foundation Medicine, Inc.
    FEI Number
    3010679023
    Product Code
    PQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2018
    Posted
    December 20, 2018
    Terminated
    April 17, 2020
    Address
    150 2nd St, Cambridge, MA, 02141-2115

    Description

    FoundationOne CDx Test Results

    Reason

    An incorrect test result for a single analyte may have been reported for up to 800 physician reports

    Action

    On October 31, 2108, an outreach program was implemented by Foundation Medicine's Medical Affairs team to advise ordering physicians who received reports of possibility that the relevant reports could contain an incorrect test result.

    Distribution

    US nationwide

    Quantity

    800 reports