Ion Torrent Genexus Dx with software recall (Life Technologies Holdings Pte Ltd)
Medical deviceClass IIOngoing
Summary: Life Technologies Holdings Pte Ltd is recalling Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer. Reason: DNA or RNA sequencing system software has vulnerabilities.
What is being recalled
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
Why
DNA or RNA sequencing system software has vulnerabilities.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK. (states named: Arizona, California, Colorado, Kentucky, Louisiana, Massachusetts, North Carolina, New York, Oklahoma, Pennsylvania)
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0211-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 14, 2026 |
| Reported | October 28, 2026 |
| Company | Life Technologies Holdings Pte Ltd |
| Company location | Singapore, Singapore |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 16 |
More recalls from Life Technologies Holdings Pte Ltd · all medical device recalls · recalls from August 2026