BEUDAMED
    FDA Recall Terminated

    Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3

    Recall: Z-0678-03 · Initiated January 17, 2003

    Recall

    Recall Number
    Z-0678-03
    Event Number
    25499
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 17, 2003
    Posted
    March 26, 2003
    Terminated
    May 7, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711

    Description

    Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3

    Reason

    Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.

    Action

    Firm sent notice by fax on 1/17/2003. The notice includes information about an effective workaround and indicates that the firm will announce the availability of a software correction when it''s ready.

    Distribution

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

    Quantity

    520