Torrent Suite Dx Software (Life Technologies) – Vulnerability Risk (2024)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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- A46
Brand
Life Technologies Corporation
Lot Codes / Batch Numbers
UDI: 10190302017848, 10190302016810 Torrent Suite Dx Software versions 5.14 and earlier
Products Sold
UDI: 10190302017848;10190302016810 Torrent Suite Dx Software versions 5.14 and earlier
Life Technologies Corporation is recalling Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD i due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026