BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.

    Recall: Z-1460-05 · Initiated July 19, 2005

    Recall

    Recall Number
    Z-1460-05
    Event Number
    32801
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    LCD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 19, 2005
    Posted
    September 1, 2005
    Terminated
    March 13, 2006
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.

    Reason

    Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.

    Action

    Letters dated 7/19/2005 with instructions to process QC fluid according to the IFU when processing patient samples. When replacement product arrives, instructions are to destroy the remaining inventory of the recalled lots.

    Distribution

    The product was shipped nationwide and to Ortho-Clinical/J&J affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.

    Quantity

    443 boxes