BEUDAMED
    FDA Recall Terminated

    Dengue IgG ELISA 96 Well Kit, Catalog Number: DE050G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    Recall: Z-0991-2010 · Initiated August 27, 2008

    Recall

    Recall Number
    Z-0991-2010
    Event Number
    50691
    Firm
    Calbiotech Inc
    FEI Number
    3002346973
    Product Code
    NWY
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 27, 2008
    Posted
    March 5, 2010
    Terminated
    March 5, 2010
    Address
    10461 Austin Dr, Ste G, Spring Valley, CA, 91978-1524

    Description

    Dengue IgG ELISA 96 Well Kit, Catalog Number: DE050G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    Reason

    The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.

    Action

    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.

    Distribution

    FL, and VA

    Quantity

    16 kits