BEUDAMED
    FDA Enforcement Class II Ongoing

    T-SPOT.TB REF TB.300 US

    Recall: Z-1641-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1641-2022
    Event ID
    90654
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    OXFORD IMMUNOTEC LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2022
    Initiation Date
    July 7, 2022
    Classification Date
    August 26, 2022
    Address
    143 Park Road, Abingdon, N/A, United Kingdom

    Description

    T-SPOT.TB REF TB.300 US

    Reason

    Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.

    Code Info

    Model/Catalog Number: TB.300 US UDI-DI Code: 15051716000305 Lot Number: TEC4000098

    Distribution

    U.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None

    Quantity

    81 units