BEUDAMED
    FDA Recall Terminated

    Misys Laboratory with Lab Access Results application for versions 5.3 and later.

    Recall: Z-0938-05 · Initiated May 13, 2005

    Recall

    Recall Number
    Z-0938-05
    Event Number
    32174
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 13, 2005
    Posted
    June 28, 2005
    Terminated
    February 10, 2006
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711-3609

    Description

    Misys Laboratory with Lab Access Results application for versions 5.3 and later.

    Reason

    Software anomaly may rarely allow modification of previously reported specimen results.

    Action

    Product Safety Notice PSN-05-01 was sent by fax on May 13, 2005 and includes a procedural work-around to avoid the defect until the firm is able to provide a software patch.

    Distribution

    Nationwide and United Kingdom, Ireland, Denmark, Canada, Saudi Arabia, United Arab Emirates

    Quantity

    258