BEUDAMED
    FDA Recall Terminated

    Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055

    Recall: Z-0961-03 · Initiated March 19, 2001

    Recall

    Recall Number
    Z-0961-03
    Event Number
    26402
    Firm
    Zeus Scientific Inc
    FEI Number
    2242436
    Product Code
    LJB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 19, 2001
    Posted
    July 2, 2003
    Terminated
    October 3, 2006
    Address
    200 Evans Way, Branchburg, NJ, 08876

    Description

    Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055

    Reason

    Mix-up between low positive and negative controls.

    Action

    Recall letter was sent via DHL to Biotest on 3/19/2001. Product was to be returned to Zeus.

    Distribution

    NJ

    Quantity

    15 kits