BEUDAMED
    FDA Recall Terminated

    VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.

    Recall: Z-0077-2007 · Initiated March 6, 2006

    Recall

    Recall Number
    Z-0077-2007
    Event Number
    36184
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 6, 2006
    Posted
    October 27, 2006
    Terminated
    June 18, 2008
    Address
    100 Indigo Creek Drive, Rochester, NY, 14626

    Description

    VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.

    Reason

    Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)

    Action

    On 3/06/06, all domestic end-users were sent "URGENT PRODUCT CORRECTION NOTIFICATION" letters (dated 3/06/06) by fax and FedEx, informing the users of the problem. The users were also notified by phone. OCD also notified its affiliates in France and the UK of the issue for notifying their customers of the problem.

    Distribution

    Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France.

    Quantity

    3 Domestic, 6 Foreign