BEUDAMED
    FDA Enforcement Class II Terminated

    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

    Recall: Z-1480-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1480-2018
    Event ID
    79649
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Life Technologies Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 2, 2018
    Initiation Date
    February 8, 2018
    Classification Date
    April 20, 2018
    Termination Date
    May 12, 2020
    Address
    7335 Executive Way, N/A, Frederick, MD, 21704-8354, United States

    Description

    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

    Reason

    The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.

    Code Info

    Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441

    Distribution

    Distributed to states: AZ, CA, NC, TX, and VA.

    Quantity

    30