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

FDA device recall Z-1426-2024 · posted 2024-03-29 · Open, Classified

Recall details

Recalling firm

Life Technologies Corporation

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

Action taken

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

Root cause

Software design

Status

Open, Classified

Product code

PFF

Quantity affected

28 units

Distribution

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

Date initiated

2024-02-07

Date posted

2024-03-29

Location

Frederick, MD