BEUDAMED
    FDA Recall Terminated

    BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027

    Recall: Z-0212-2009 · Initiated July 2, 2008

    Recall

    Recall Number
    Z-0212-2009
    Event Number
    49385
    Firm
    Inverness Medical BioStar Inc.
    FEI Number
    1720655
    Product Code
    GNX
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 2, 2008
    Posted
    November 3, 2008
    Terminated
    November 4, 2008
    Address
    331 S 104th St, Louisville, CO, 80027-9713

    Description

    BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027

    Reason

    Diagnostic kits for flu were distributed with incorrect components.

    Action

    Consignees were notified by a Important Customer Notification letter on 7/2/2008 and told to re-examine patient records that indicated a negative result and to destroy any remaining recalled product. The accompanying record should be filled out and faxed to Technical Service. If consignees further distributed any kits, they were to forward the notification to these accounts to assure that patient results were reviewed, and destruction of remaining kits could be verified. For assistance, customers can call 800-637-3717.

    Distribution

    Nationwide Distribution --- including state of IL.

    Quantity

    509 kits