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Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer

Class II
Recalling firm
Life Technologies Holdings Pte Ltd
Reason for recall
DNA or RNA sequencing system software has vulnerabilities.
Affected products (lot / model / serial)
UDI-DI: 10190302018883, Software: 6.8.2.1 and earlier. Sequencer UDI-DI: 10190302017794. Sequencer Serial Numbers: 2619124040913, 2619726010247, 2619124060941, 2619124060942, 2619725090229, 2619725100238, 2619122070666, 2619725080220, 2619725090226, 2619726010251, 2619726020265, 2619725090225, 2619725100235, 2619725050205, 2619726010249, 2619122070658
Units affected
16
Distribution pattern
US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.
Firm location
Singapore, Singapore
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-0211-2027
Recall initiated
August 14, 2026
FDA classification date
October 22, 2026
FDA report date
October 28, 2026
FDA event ID
99885
Last updated on HTM Vibe
November 3, 2026
View on openFDA