BEUDAMED
    FDA Recall Terminated

    Mysis Laboratory version 6.1

    Recall: Z-0939-05 · Initiated May 10, 2005

    Recall

    Recall Number
    Z-0939-05
    Event Number
    32231
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 10, 2005
    Posted
    June 28, 2005
    Terminated
    August 30, 2005
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711-3609

    Description

    Mysis Laboratory version 6.1

    Reason

    When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted.

    Action

    Firm sent Product Safety Notice PSN 05-02 on May 10, 2005 which also provides a procedural work-around and an invitation to obtain a service pack to correct the software flaw.

    Distribution

    Nationwide and United Kingdom and Denmark

    Quantity

    21