BEUDAMED
    FDA Recall Terminated

    VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626

    Recall: Z-0173-06 · Initiated October 12, 2005

    Recall

    Recall Number
    Z-0173-06
    Event Number
    33896
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    LEH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 12, 2005
    Posted
    November 18, 2005
    Terminated
    September 22, 2008
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626

    Reason

    Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.

    Action

    Letters dated 10/12/2005 issued to end users in the U.S. Customers advised they may continue to use the VANC Reagent if their laboratory processes QC fluids according to protocol. A return reply form is included. Foreign affiliates were notified via e-mail on 10/12/2005.

    Distribution

    Product shipped to medical facilities (end-users) in the U.S. and to 9 International J&J affiliates in Australia, Canada, Caribbean, Chile, France, Philippines, Portugal, Taiwan, UK/Northern Europe, Israel, Saudi Arabia and Venezuela.

    Quantity

    784 boxes x 6 packs x 50 tests