BEUDAMED
    FDA Enforcement Class II 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 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1230-2016
    Event ID
    73384
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 30, 2016
    Initiation Date
    February 2, 2016
    Classification Date
    March 22, 2016
    Termination Date
    August 16, 2016
    Address
    19300 Germantown Rd, N/A, Germantown, MD, 20874-1415, United States

    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.

    Code Info

    CODE(S): a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016 b. Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016 c. Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016 d. Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016 e. Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016

    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