{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "176347",
      "product_res_number": "Z-0186-2020",
      "event_date_initiated": "2019-09-26",
      "event_date_created": "2019-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-11-23",
      "res_event_number": "83786",
      "product_code": "PFF",
      "k_numbers": [
        "K170299"
      ],
      "product_description": "Torrent Suite Dx Software Version (IUO) 5.4\nCatalog Number: A31774\nOEM Customer Software: Sentosa SQ Suite Software  v5.6.15",
      "code_info": "The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type",
      "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": "Gabriella Armin\n773-673-3347",
      "reason_for_recall": "Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant",
      "root_cause_description": "Software design",
      "action": "1. Notify all PGM Dx users in your facility of this issue.\n\n2.  Require that the Test_Report.pdf file be used for reporting results for all future sample tests.\n\n3. Require that the Test_Report.pdf file be used to confirm ALL positive call results.\nFor sample result reporting that use the Test_Report.pdf file and NOT the Target_Summary.tab file, the results are valid, and no further action is needed.\n\nFor sample result reporting that use the Target_Summary.tab file on the Torrent SuiteTM Dx software versions indicated above, customers MUST review ALL results obtained using the Target_Summary.tab file against the results shown in the Test_Report.pdf file to identify any occurrences of possible false positive reporting.\n\n4. If you have shared reports using results from the Target_Summary.tab file, outside of your facility, you MUST notify those customers or facilities to take the required action.\n\n5. Please complete the following Customer Response Sheet and submit sheet, along with this letter, by emailing a scanned copy to nitesh.patel@thermofisher.com.\n\nIf you have any technical questions or concerns, please contact Technical Support at 800-955-6288 option 4 or techsupport@thermofisher.com",
      "product_quantity": "total of Ion+vela +chassis =400 units",
      "distribution_pattern": "states : AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, WA\n\nOUS: South Korea, ITALY, China, Japan, Singapore, Germany, TAIWAN, Poland",
      "openfda": {
        "k_number": [
          "DEN130011",
          "K170299"
        ],
        "registration_number": [
          "3014150341",
          "3009875001",
          "3006296346",
          "3011104381",
          "3003673482",
          "3007287152",
          "3003218906",
          "3007102730",
          "3015529000",
          "3003335080",
          "3009207631"
        ],
        "fei_number": [
          "3014150341",
          "3009875001",
          "3011104381",
          "3003673482",
          "3007287152",
          "3003218906",
          "3007102730",
          "3015529000",
          "3003335080",
          "3005095756",
          "3009207631"
        ],
        "device_name": "High Throughput Dna Sequence Analyzer",
        "medical_specialty_description": "Immunology",
        "regulation_number": "862.2265",
        "device_class": "2"
      }
    }
  ]
}