BEUDAMED
    FDA Recall Terminated

    Calculator/ Data Processing Module for Clinical Use.

    Recall: Z-0235-04 · Initiated September 25, 2003

    Recall

    Recall Number
    Z-0235-04
    Event Number
    27575
    Firm
    Misys Healthcare Systems
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 25, 2003
    Posted
    December 18, 2003
    Terminated
    September 3, 2004
    Address
    4801 E Broadway Blvd, Tucson, AZ, 85711-3609

    Description

    Calculator/ Data Processing Module for Clinical Use.

    Reason

    Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.

    Action

    Firm has issued notifcation to all affected customers.

    Distribution

    US, UK, Ireland, Denmark, Canada, Bermuda, Saudi Arabia and United Arab Emirates

    Quantity

    485