BEUDAMED
    FDA Recall Terminated

    QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)

    Recall: Z-1230-2016 · Initiated February 2, 2016

    Recall

    Recall Number
    Z-1230-2016
    Event Number
    73384
    Firm
    Qiagen Sciences LLC
    FEI Number
    3003572099
    Product Code
    NCD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 2, 2016
    Terminated
    August 16, 2016
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415

    Description

    QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)

    Reason

    Potential for obtaining a false positive result due to the possibility of endotoxin presence.

    Action

    QIAGEN sent an "Urgent - Notification of Market Withdrawal" dated February 2, 2016, to all affected customers. The letter identify the product the problem and the action needed to be taken by the customer. Immediately discontinue use of this lot and discard any remaining inventory. Please acknowledge receipt of this notification and actions taken by completing the information on the next page, and return to: [email protected] or fax +1-661-775-7479. QIAGEN apologizes for any inconvenience this market withdrawal has caused, and continues to take every effort possible to ensure the highest quality of product is always available to our valued customers around the globe. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative should you have any questions or concerns. For further questions, please call ( 240) 686-7500.

    Distribution

    Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.

    Quantity

    The total amount of product distributed 152,900 Tubes