BEUDAMED
    FDA Enforcement Class II Terminated

    SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.

    Recall: Z-2143-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2143-2012
    Event ID
    62023
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SCC Soft Computer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    August 15, 2012
    Initiation Date
    October 17, 2011
    Classification Date
    August 3, 2012
    Termination Date
    September 3, 2014
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760, United States

    Description

    SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.

    Reason

    On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu.

    Code Info

    SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13.

    Distribution

    US Nationwide Distribution

    Quantity

    88