BEUDAMED
    FDA Recall Terminated

    @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.

    Recall: Z-3054-2011 · Initiated July 6, 2011

    Recall

    Recall Number
    Z-3054-2011
    Event Number
    59276
    Firm
    Jay Bird Investments Inc
    FEI Number
    3007282976
    Product Code
    GTY
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    July 6, 2011
    Posted
    August 23, 2011
    Terminated
    June 20, 2012
    Address
    12 S Main St, STE 206 208, Layton, UT, 84041-3710

    Description

    @ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.

    Reason

    Home Strep Test does not qualify as a Class I device and needs pre-market approval.

    Action

    Jay Bird Investments, Inc. sent a notification letter dated July 6, 2011 to customers. The letter describes the product, problem and the actions to be taken. The customers were instructed to notify retailers and remove the product from the shelves. For questions regarding disposition of the product please contact Myron Bouwhuis at 801-721-3528.

    Distribution

    Nationwide Distribution (USA) including the states of OR and UTAH.

    Quantity

    7,541