BEUDAMED
    FDA Recall Terminated

    The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1).

    Recall: Z-0557-06 · Initiated August 8, 2005

    Recall

    Recall Number
    Z-0557-06
    Event Number
    33128
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    LJY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 8, 2005
    Posted
    February 23, 2006
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1).

    Reason

    Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG.

    Action

    Consignees were contacted by telephone and then the firm sent a fax titled 'Diasorin Customer Notification' dated 8/8/05 that documented the information as provided by telephone.

    Distribution

    Nationwide. AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX.

    Quantity

    22