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CLASS II · ModerateFDA

Life Technologies Holdings Pte Ltd recalls Ion Torrent Genexus Dx with software

📅 Aug 14, 2026 · 📍 Nationwide
Recalling company
Life Technologies Holdings Pte Ltd
Product
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 14, 2026
Reported
Oct 28, 2026
Distribution
US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.
Status
Ongoing
Quantity
16
Lot / codes
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
Company location
Singapore
Recall type
Voluntary: Firm initiated
Recall number
Z-0211-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0211-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.