BEUDAMED
    FDA Recall Open, Classified

    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166

    Recall: Z-1426-2024 · Initiated February 7, 2024

    Recall

    Recall Number
    Z-1426-2024
    Event Number
    94122
    Firm
    Life Technologies Corporation
    FEI Number
    3003335080
    Product Code
    PFF
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 7, 2024
    Posted
    March 29, 2024
    Address
    7335 Executive Way, Frederick, MD, 21704-8354

    Description

    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166

    Reason

    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument

    Action

    Thermo Fisher issued a Medical Device Advisory Notice on Feb 7 2024 to US Customers. Letter includes instructions for mitigation of the vulnerabilities,health risk and action to take: Therefore, Thermo Fisher Scientific advises customers using impacted versions of Torrent Suite Dx to disconnect the Ion PGM Dx sequencer, Ion OneTouch instrument and the Ion PGM" Torrent Server from the customer's network to mitigate the vulnerabilities. To access the data results generated on the instrument, Thermo Fisher Scientific recommends connecting the Ion OneTouch instrument and the Ion PGM Dx Sequencer directly into the Ion PGM Torrent Server. Customers can access the Ion PGM Torrent Server by connecting their laptops (with WiFi disabled) directly into the server. Please have your IT department contact your local Thermo Fisher Scientific field support team for mitigation guidance. Thermo Fisher Scientific advises the user facility to have proper network firewalls and controlled access to laboratory equipment and laboratory systems. We will keep you informed if new or additional information becomes available. Contacting your support representative

    Distribution

    US Nationwide distribution in the states of CA, IN, NC OR, TN.

    Quantity

    28 units