BEUDAMED
    FDA Recall Terminated

    The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.

    Recall: Z-0541-05 · Initiated December 23, 2004

    Recall

    Recall Number
    Z-0541-05
    Event Number
    31078
    Firm
    Diamedix Corporation
    FEI Number
    1044713
    Product Code
    LHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 23, 2004
    Posted
    February 15, 2005
    Terminated
    May 3, 2012
    Address
    2140 N Miami Ave, Miami, FL, 33127-4916

    Description

    The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.

    Reason

    The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.

    Action

    Direct customers were notified by letter on 12/23/2004 by Federal Express.100% of the total customers will be contacted. The letter instructed the consignees to discontinue use immediately and arrange to return the product to Diamedix.

    Distribution

    Distributed to Domestic customers only.

    Quantity

    178