Z-1426-2024Class II

Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended...

Name: Z-1426-2024 Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended...
Creator: Life Technologies Corporation
Published: 2024-02-07
License: https://open.fda.gov/license/

Life Technologies Corporation / initiated 2024-02-07 / Open, Classified / root cause: software

FDA source

Life Technologies Corporation began a recall of 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)... on 2024-02-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1426-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-07
Posted: 2024-03-29
Recalling firm: Life Technologies Corporation
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- 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
Product code: PFF High Throughput Dna Sequence Analyzer
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
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
Quantity in commerce: 28 units
Distribution: US Nationwide distribution in the states of CA, IN, NC OR, TN.
Product codes and lots: UDI: 10190302017848;10190302016810 Torrent Suite Dx Software versions 5.14 and earlier

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1426-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1426-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-03-29

Product code PFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)