CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report

Ion Torrent Genexus Dx recalled by Life Technologies Holdings Pte

Life Technologies Holdings Pte is recalling Ion Torrent Genexus Dx, distributed nationwide in the US. The recall was initiated on 14 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled16

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0211-2027
FDA event ID: 99885
Recalling firm: Life Technologies Holdings Pte, Singapore
Classification: Class II
Status: Ongoing
Recall initiated: 14 Aug 2026
FDA classified: 22 Oct 2026
Reported: 28 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

14 Aug 2026	Recall initiated by company
22 Oct 2026	Classified by FDA	+69 days
28 Oct 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

DNA or RNA sequencing system software has vulnerabilities.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.

Nationwide Arizona California Colorado Kentucky Louisiana Massachusetts North Carolina New York Oklahoma Pennsylvania

Questions about this recall

Why was it recalled?

DNA or RNA sequencing system software has vulnerabilities.

Which lots are 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

Where was it sold?

US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Life Technologies Holdings Pte

All 5

Reported	Class	Recall	Company	Reason	Where
30 Oct 2019Device	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states
30 Oct 2019Device	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states
30 Oct 2019Device	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states
30 Oct 2019Device	CLASS II	Torrent Suite Dx recalled by Life Technologies Holdings Pte	Life Technologies Holdings Pte	Device Malfunction	17 states

Other Medical Software recalls

All 935

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Metatarsophalangeal (MTP) Implant is a sterile recalled by restor3d	restor3d	Sterility	Nationwide
21 Oct 2026Device	CLASS II	Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Device Malfunction	CA
14 Oct 2026Device	CLASS II	Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide