BEUDAMED
    FDA Recall Terminated

    Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.

    Recall: Z-0238-04 · Initiated July 21, 2003

    Recall

    Recall Number
    Z-0238-04
    Event Number
    27499
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2003
    Posted
    July 20, 2004
    Terminated
    November 15, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711-3609

    Description

    Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.

    Reason

    Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients.

    Action

    A temporary procedural workaround was communicated by fax to customers in Product Safety Notice PSN-03-L33 on July 21, 2003. Asecond Notice (L33A) was sent to customers to futher facilitate the recall.

    Distribution

    Nationwide, Canada, Saudi Arabia, United Kingdom.

    Quantity

    125