BEUDAMED
    FDA Recall Terminated

    Misys Laboratory System, versions 5.2, 5.23 and 5.3

    Recall: Z-1007-03 · Initiated June 10, 2003

    Recall

    Recall Number
    Z-1007-03
    Event Number
    26541
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 10, 2003
    Posted
    July 15, 2003
    Terminated
    April 23, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711

    Description

    Misys Laboratory System, versions 5.2, 5.23 and 5.3

    Reason

    Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations.

    Action

    Notification was sent by fax under Product Safety Notice, PSN-03-L27 on June 10, 2003 also under PSN-03-L27 on June 13, 2003 to sites with MIM functionality.

    Distribution

    Nationwide and to Ireland, Canada, Denmark, Bermuda, UK, Saudi Arabia, United Arab Emirates.

    Quantity

    467