Device recall
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
- Recall number
- Z-0211-2027
- Event id
- 99885
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Life Technologies Holdings Pte Ltd
- Report date
- Oct 28, 2026
- Posted
- Oct 22, 2026
- Initiated
- Aug 14, 2026
- Center classification date
- Oct 22, 2026
- Product code
- PFF
- Device type
- High Throughput Dna Sequence Analyzer
- Reason
- DNA or RNA sequencing system software has vulnerabilities.
- Root cause
- Software design
- Quantity
- 16
- Code info
- 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
- Distribution
- US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Singapore, Singapore