BEUDAMED
    FDA Recall Terminated

    Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.

    Recall: Z-1506-2009 · Initiated April 6, 2009

    Recall

    Recall Number
    Z-1506-2009
    Event Number
    51871
    Firm
    Binax, Inc. dba IMPD
    FEI Number
    1221359
    Product Code
    GTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 6, 2009
    Posted
    June 24, 2009
    Terminated
    January 6, 2010
    Address
    10 Southgate Rd, Scarborough, ME, 04074

    Description

    Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.

    Reason

    Potential for false positive Strep A results.

    Action

    Inverness Medical notified Customers by letter sent via Fedex April 6, 2009 . The letter included a request for a response from the customer. The product is discontinued.

    Distribution

    Nationwide.

    Quantity

    1,729 kits