BEUDAMED
    FDA Enforcement Class II Terminated

    SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.

    Recall: Z-1573-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1573-2014
    Event ID
    67970
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SCC Soft Computer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    May 21, 2014
    Initiation Date
    January 29, 2014
    Classification Date
    May 9, 2014
    Termination Date
    November 3, 2014
    Address
    5400 Tech Data Drive, Clearwater, FL, 33760, United States

    Description

    SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.

    Reason

    When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.

    Code Info

    SA HIS version 4.0.7.0

    Distribution

    Distributed in IL.

    Quantity

    1