{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  "results": [
    {
      "cfres_id": "222804",
      "product_res_number": "Z-0211-2027",
      "event_date_initiated": "2026-08-14",
      "event_date_posted": "2026-10-22",
      "recall_status": "Open, Classified",
      "res_event_number": "99885",
      "product_code": "PFF",
      "product_description": "Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer",
      "code_info": "UDI-DI: 10190302018883, Software: 6.8.2.1 and earlier.\nSequencer UDI-DI: 10190302017794.\nSequencer Serial Numbers: \n2619124040913,\n2619726010247,\n2619124060941,\n2619124060942,\n2619725090229, \n2619725100238,\n2619122070666, \n2619725080220,\n2619725090226,\n2619726010251,\n2619726020265,\n2619725090225,\n2619725100235,\n2619725050205,\n2619726010249,\n2619122070658",
      "firm_fei_number": "3003673482",
      "recalling_firm": "Life Technologies Holdings Pte Ltd",
      "address_1": "Blk 33 Marsiling Ind Estate Road 3 #07-06",
      "city": "Singapore",
      "country": "Singapore",
      "additional_info_contact": "6362-9300",
      "reason_for_recall": "DNA or RNA sequencing system software has vulnerabilities.",
      "root_cause_description": "Software design",
      "action": "On 8/14/2026, recall notices were emailed to customers who were informed of the following:\n\nOnce the software becomes available, your field support specialist or your local Service and Support representative will reach out to schedule a software upgrade.\n\nFirm recommends that customers back up their data before any software upgrades. Please refer to \"Manage backup settings and restore runs (administrator)\" section of the user guide.\n\nComplete and return the CUSTOMER RESPONSE Acknowledgement and Receipt Form via email to genexusdx.notifications@thermofisher.com; and also contact the firm at this email address is you have any technical questions or concerns.",
      "product_quantity": "16",
      "distribution_pattern": "US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.",
      "openfda": {
        "k_number": [
          "DEN130011",
          "K170299"
        ],
        "registration_number": [
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          "3009875001",
          "3003673482",
          "3015529000",
          "3011104381",
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          "3007287152",
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          "3007287152",
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        ],
        "device_name": "High Throughput Dna Sequence Analyzer",
        "medical_specialty_description": "Immunology",
        "regulation_number": "862.2265",
        "device_class": "2"
      }
    }
  ]
}