FDA-Device2026-10-22Class IIPROCESSING DEFECT
Life Technologies Ion Torrent Genexus Dx software recalled for security vulnerabilities
What this means
The Ion Torrent Genexus Dx DNA/RNA sequencing system software (version 6.8.2.1 and earlier) contains security vulnerabilities that could potentially be exploited. Life Technologies has identified 16 affected sequencers across multiple U.S. states.
- If you operate an Ion Torrent Genexus Dx sequencer, contact Life Technologies for guidance on software updates or corrective measures.
- Check the serial number of your sequencer against the affected list provided by the manufacturer.
- Do not delay sequencing work; contact your Life Technologies representative for next steps.
The agency's original wording
Hazard
DNA or RNA sequencing system software has vulnerabilities.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.
Affected count
16
Manufactured in
Blk 33 Marsiling Ind Estate Road 3, #07-06, Singapore, Singapore
Products
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0211-2027Want us to check the next one for you?
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