BEUDAMED
    FDA Recall Terminated

    VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

    Recall: Z-0913-05 · Initiated March 15, 2005

    Recall

    Recall Number
    Z-0913-05
    Event Number
    31719
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    KLI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 15, 2005
    Posted
    June 21, 2005
    Terminated
    February 10, 2006
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

    Reason

    Potential for positively biased results in QC and patient samples.

    Action

    Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack.

    Distribution

    Nationwide distribution. Product shipped worldwide via J&J foreign affiliates.

    Quantity

    Domestic - 1359; International - 840