BEUDAMED
    FDA Enforcement Class II Terminated

    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

    Recall: Z-1038-2015 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1038-2015
    Event ID
    70021
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SCC Soft Computer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    February 11, 2015
    Initiation Date
    May 20, 2014
    Classification Date
    February 2, 2015
    Termination Date
    May 16, 2016
    Address
    5400 Tech Data Drive, N/A, Clearwater, FL, 33760, United States

    Description

    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

    Reason

    The interface fails to send abnormal flags for Reference Lab test results.

    Code Info

    4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present

    Distribution

    Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.

    Quantity

    48