BEUDAMED
    FDA Recall Terminated

    Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results

    Recall: Z-1217-03 · Initiated July 22, 2003

    Recall

    Recall Number
    Z-1217-03
    Event Number
    27029
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 22, 2003
    Posted
    September 11, 2003
    Terminated
    June 25, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711

    Description

    Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results

    Reason

    Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.

    Action

    Product Safety Notice, PSN-03-L04 was issued to all affected customers by fax on 07/22/2003. This included a procedural workaround to use until a software correction is made available or to use indefinitly at the user''s discretion. Completion of the recall , including release of the software fix is expected in December 2003.

    Distribution

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

    Quantity

    171