BEUDAMED
    FDA Enforcement Class II Terminated

    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture

    Recall: Z-1911-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1911-2016
    Event ID
    74140
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integrated Science Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 15, 2016
    Initiation Date
    February 19, 2016
    Classification Date
    June 3, 2016
    Termination Date
    February 28, 2017
    Address
    1215 George C Wilson Dr Unit A4, N/A, Augusta, GA, 30909-5700, United States

    Description

    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture

    Reason

    Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.

    Code Info

    Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043

    Distribution

    Nationwide distribution to CA only.

    Quantity

    2625 kits