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Class IIOngoing

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

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Life Technologies Holdings Pte Ltd
Reason
DNA or RNA sequencing system software has vulnerabilities.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99885…

Products

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

    Codes/lots: 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, 2619122070658Quantity: 16Recall no. Z-0211-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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