BEUDAMED
    FDA Recall Terminated

    Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.

    Recall: Z-1127-03 · Initiated June 18, 2003

    Recall

    Recall Number
    Z-1127-03
    Event Number
    26505
    Firm
    Meridian Bioscience Inc
    FEI Number
    1524213
    Product Code
    LFZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2003
    Posted
    August 12, 2003
    Terminated
    March 29, 2004
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244

    Description

    Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.

    Reason

    The Low Positive Standard kit component is losing potency that may result in false positive test results.

    Action

    The firm notified their customers by telephone and fax on 6/18/2003.

    Distribution

    The kits were shipped to end-users located in CA, UT, NY, MD, KY; and to a foreign distributor in Belgium.

    Quantity

    43 kits