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    Genexpert® DX System Installation Qualification Report

    Uploaded by

    Bryan Gonzales
    QC GX

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Genexpert® DX System Installation Qualification Report

    Uploaded by

    Bryan Gonzales
    68 views2 pages
    QC GX

    Original Title

    Installation_Qualification_2020.07.27_15.24.12

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    © © All Rights Reserved

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    QC GX

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    68 views2 pages

    Genexpert® DX System Installation Qualification Report

    Uploaded by

    Bryan Gonzales
    QC GX

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    CENTRO MEDICO BUEN SAMARITANO CAT-OLANCHO 07/27/20 15:24:12

    836904

    GeneXpert® Dx System
    Installation Qualification Report

    This report provides documented evidence of the installation of this GeneXpert® Dx System.

    System Information
    Software Version Status
    GeneXpert® Dx System 5.1 Pass
    Java Runtime Environment 1.8.0_131 Pass
    GX_Utils.DLL 0.8.4.0 Pass
    SQL Database Microsoft SQL Server 13.00.4001 Pass
    Database gx_db 3.0.9.0 Pass
    Operating System Windows 10 10.0 Pass
    CIT Plug-In 1 Pass

    Instrument Information
    Instrument B
    Instrument S/N Gateway Firmware
    836904 2.0.18

    Module Name Module S/N Module Firmware Internal Temp Status


    °C
    B1 799664 3.3.3 29.7 Pass
    B2 799751 3.3.3 29.7 Pass
    B3 799774 3.3.3 29.4 Pass
    B4 800370 3.3.3 28.1 Pass

    Shaded Modules = Reporter is out of calibration.

    Available Assays
    Assay Name Version Assay Type
    Xpert Flu CE-IVD 7 In Vitro Diagnostic
    Xpert Xpress SARS-CoV-2 1 In Vitro Diagnostic

    GeneXpert® Dx System Version 5.1 Page 1 of 2


    CENTRO MEDICO BUEN SAMARITANO CAT-OLANCHO 07/27/20 15:24:12
    836904

    GeneXpert® Dx System
    Installation Qualification Report

    Installation of networked instruments complies with the setup requirements specified in the GeneXpert® Dx
    System Operator Manual, 'Installation' section.

    Verified by Date
    This IQ is acceptable if all System Information and Instrument Information are listed as 'Pass'. All instrument
    modules that are listed as 'Pass' are available for use.

    Acceptance: [ ] Acceptable [ ] Not Acceptable

    Performed by Date

    Reviewed and approved by Date

    GeneXpert® Dx System Version 5.1 Page 2 of 2

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