BEUDAMED
    FDA Recall Terminated

    Misys Laboratory System versions 5.23 and 5.3

    Recall: Z-0791-03 · Initiated March 26, 2003

    Recall

    Recall Number
    Z-0791-03
    Event Number
    25993
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 26, 2003
    Posted
    May 8, 2003
    Terminated
    April 21, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711

    Description

    Misys Laboratory System versions 5.23 and 5.3

    Reason

    With SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests.

    Action

    The firm faxed notification on 3/26/2003 along with a response form and a temporary procedural workaround in Product Safety Notice PSN-03-L13.

    Distribution

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

    Quantity

    463