{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192246",
      "product_res_number": "Z-0854-2022",
      "event_date_initiated": "2022-02-22",
      "event_date_created": "2022-03-31",
      "recall_status": "Completed",
      "res_event_number": "89699",
      "product_code": "PFF",
      "product_description": "Illumina NextSeq 550Dx, REF: 20005715, CE, IVD",
      "code_info": "Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125",
      "firm_fei_number": "3003218906",
      "recalling_firm": "Illumina, Inc.",
      "address_1": "5200 Illumina Way",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92122-4616",
      "additional_info_contact": "Karen Gutekunst\n858-255-5541",
      "reason_for_recall": "There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due  to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.",
      "root_cause_description": "Device Design",
      "action": "On February 22, 2022 Illumina issued a \"Urgent Field Safety\" recall notice to all affected consignees via E-Mail. The firm issued an amended \"Urgent Medical Device\" recall notice on March 11, 2022 via email to provide consignees with additional information.  In addition to notifying consignees about the recall, the firm asked consignees to take the following actions:\n\n 1. Complete the attached FSN2022-125 verification form to confirm receipt of the notification and return the form to Technical Support at techsupport@illumina.com within 5 business days. \n\n2. If you have not already sent Illumina the Verification Form attached to FSN2022-1215, please complete the attached copy of the form and return it to Technical Support at techsupport@illumina.com within 5 business days. No additional action is required at this time\n\n3. Please note, if an operator experiences an adverse event with the use of this product, user may report this to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.",
      "product_quantity": "674 instruments",
      "distribution_pattern": "US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN\nOUS: Australia\tAustria\tBelgium\tChile\tChina\tDenmark\tFinland\tFrance\tGermany\tHungary\tIreland\tItaly\tJapan\tLatvia\tNetherlands\tNorway\tPoland\tPortugal\tRomania\tRussian Federation\tSaudi Arabia\tSingapore\tSlovakia\tSouth Africa\tSouth Korea\tSpain\tSweden\tSwitzerland\tTurkey\tUnited Arab Emirates\tUnited Kingdom\tVietnam",
      "openfda": {
        "k_number": [
          "DEN130011",
          "K170299"
        ],
        "registration_number": [
          "3009875001",
          "3015529000",
          "3003335080",
          "3014150341",
          "3007287152",
          "3009207631",
          "3003673482",
          "3006296346",
          "3011104381",
          "3003218906",
          "3007102730"
        ],
        "fei_number": [
          "3005095756",
          "3009875001",
          "3015529000",
          "3003335080",
          "3014150341",
          "3007287152",
          "3009207631",
          "3003673482",
          "3011104381",
          "3003218906",
          "3007102730"
        ],
        "device_name": "High Throughput Dna Sequence Analyzer",
        "medical_specialty_description": "Immunology",
        "regulation_number": "862.2265",
        "device_class": "2"
      }
    }
  ]
}