BEUDAMED
    FDA Recall Terminated

    Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.

    Recall: Z-1093-03 · Initiated June 23, 2003

    Recall

    Recall Number
    Z-1093-03
    Event Number
    26717
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 23, 2003
    Posted
    August 7, 2003
    Terminated
    April 23, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711

    Description

    Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.

    Reason

    Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.

    Action

    Recall notice, PSN-03-L30, was sent by fax on 6-23-2003.. nb. Firm requests the afforementioned sentence be placed in the ER.

    Distribution

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

    Quantity

    157