BEUDAMED
    FDA Enforcement Class II Terminated

    SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

    Recall: Z-2865-2017 · Reported August 9, 2017

    Enforcement

    Recall Number
    Z-2865-2017
    Event ID
    77669
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Soft Computer Consultants, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2017
    Initiation Date
    May 31, 2017
    Classification Date
    August 2, 2017
    Termination Date
    August 4, 2020
    Address
    5400 Tech Data Dr, N/A, Clearwater, FL, 33760-3116, United States

    Description

    SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

    Reason

    Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.

    Code Info

    Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20

    Distribution

    US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.

    Quantity

    18 units