BEUDAMED
    FDA Recall Terminated

    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.

    Recall: Z-0137-06 · Initiated September 29, 2005

    Recall

    Recall Number
    Z-0137-06
    Event Number
    33848
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    KHO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2005
    Posted
    November 15, 2005
    Terminated
    July 31, 2007
    Address
    100 Indigo Creek Drive, Rochester, NY, 14626

    Description

    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.

    Reason

    When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negtively biased.

    Action

    Letters dated 9/29/2005 issued to all domestic customers of the VITROS ECi/ECiQ systems and to Ortho/J&J foreign affiliates. Customers instructed to immediately discontinue using reflex processing to the VITROS Anti-HBc IgM and VITROS Anti-HAV reagent packs.

    Distribution

    Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.

    Quantity

    3,507 Vitros ECi units distributed