BEUDAMED
    FDA Enforcement Class II Terminated

    SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.

    Recall: Z-2093-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2093-2021
    Event ID
    88095
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Soft Computer Consultants, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 28, 2021
    Initiation Date
    March 31, 2021
    Classification Date
    July 19, 2021
    Termination Date
    April 15, 2022
    Address
    5400 Tech Data Dr, N/A, Clearwater, FL, 33760-3116, United States

    Description

    SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.

    Reason

    Software showing wrong results reported, PDF not match HIS.

    Code Info

    Version 4.1.15.6

    Distribution

    US Distribution to: CA only

    Quantity

    1