BEUDAMED
    FDA Recall 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 · Initiated February 8, 2018

    Recall

    Recall Number
    Z-1480-2018
    Event Number
    79649
    Firm
    Life Technologies Corporation
    FEI Number
    3003335080
    Product Code
    PQP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 8, 2018
    Terminated
    May 12, 2020
    Address
    7335 Executive Way, Frederick, MD, 21704-8354

    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.

    Action

    The firm issued an Urgent: Medical Device Recall Notification, dated February 16, 2018, via e-mail and phone call to affected consignees. The letter identified the affected device and advised customers of the potential "No Call" or false positive outcomes. Users were advised that they may need an alternate method to determine the presence of ROS1 variant in previously tested patient samples, and that any future tests using the affected lot cannot be considered valid if "No Call" or "Negative" is the result. Requested action included reviewing previous results which used the affected lot. Customers are to complete the Customer Response Sheet provided and e-mail a scanned copy along with the letter to [email protected]. Questions and comments should be directed to Vineet Bansal, 408-802-2341, [email protected].

    Distribution

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

    Quantity

    30