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U.S. Department of Health and Human Services

Class 2 Device Recall Torrent Suite" Dx Software

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  Class 2 Device Recall Torrent Suite" Dx Software see related information
Date Initiated by Firm February 07, 2024
Date Posted March 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1426-2024
Recall Event ID 94122
Product Classification High throughput DNA sequence analyzer - Product Code PFF
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
Code Information UDI: 10190302017848;10190302016810 Torrent Suite Dx Software versions 5.14 and earlier
Recalling Firm/
Manufacturer		 Life Technologies Corporation
7335 Executive Way
Frederick MD 21704-8354
For Additional Information Contact SAME
240-379-4495
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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