BEUDAMED
    FDA Enforcement Class III Terminated

    Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    Recall: Z-2976-2020 · Reported September 23, 2020

    Enforcement

    Recall Number
    Z-2976-2020
    Event ID
    86003
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oxford Immunotec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 23, 2020
    Initiation Date
    July 16, 2020
    Classification Date
    September 16, 2020
    Termination Date
    September 13, 2021
    Address
    94C Innovation Drive, Milton Park, Abingdon, N/A, N/A, United Kingdom

    Description

    Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    Reason

    Incorrect expiration date included in test kit labeling and/or in Substrate component label.

    Code Info

    Manufacturing Kit Lot Numbers: TEC3321847, TEC3041811.

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA, TN, TX, and VA. The countries of Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom.

    Quantity

    583 units