BEUDAMED
    FDA Recall 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 · Initiated February 19, 2016

    Recall

    Recall Number
    Z-1911-2016
    Event Number
    74140
    Firm
    Integrated Science Systems Inc
    FEI Number
    3011450093
    Product Code
    LHJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 19, 2016
    Posted
    June 3, 2016
    Terminated
    February 28, 2017
    Address
    1215 George C Wilson Dr, Unit A4, Augusta, GA, 30909-5700

    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.

    Action

    Integrated Science Systems sent a Recall Notification letter dated March 29, 2016. Integrated Science Systems requested that unopened kits in inventory be returned. Once the root cause has been determined, the kits will be reworked and returned to INOVA for distribution. For questions call 706-922-8686.

    Distribution

    Nationwide distribution to CA only.

    Quantity

    2625 kits