BEUDAMED
    FDA Recall Terminated

    Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.

    Recall: Z-1095-03 · Initiated June 12, 2003

    Recall

    Recall Number
    Z-1095-03
    Event Number
    26589
    Firm
    Zeus Scientific Inc
    FEI Number
    2242436
    Product Code
    LFZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 12, 2003
    Posted
    August 12, 2003
    Terminated
    February 22, 2006
    Address
    200 Evans Way, Branchburg, NJ, 08876

    Description

    Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.

    Reason

    The Calibrator included within the kit may be losing reactivity.

    Action

    All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed.

    Distribution

    The product was distributed to 6 distributors and 24 direct accounts in the United States and Internationally. Canada; Sweden; Costa Rica; Czech; Indonesia.

    Quantity

    270 kits