{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "113653",
      "product_res_number": "Z-0182-2013",
      "event_date_initiated": "2012-10-03",
      "event_date_posted": "2012-10-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-12-04",
      "res_event_number": "63387",
      "product_code": "NOP",
      "k_numbers": [
        "K031953"
      ],
      "product_description": "West Nile Virus IgG DxSelect\" kit Catalog No. EL0300G\nKit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen\nWells, Catalog Number EL0351, Lot Number 121117.\n\n510(k) No. K031953\n\nThe Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.",
      "code_info": "Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117.",
      "firm_fei_number": "2023365",
      "recalling_firm": "Focus Diagnostics Inc",
      "address_1": "11331 Valley View St",
      "city": "Cypress",
      "state": "CA",
      "postal_code": "90630-5366",
      "additional_info_contact": "714-220-1900",
      "reason_for_recall": "The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a\nhigher false positive rate.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Focus Diagnostics Inc.,  sent a Urgent Medical Device Recall letter dated October 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nOur records indicate that you received at least one of the effected lots in the month of August 2012. Please document the number of kits in your inventory on the table below, even if zero (0), and fax to 562-240-6526.\n\nFor further questions please call (714) 220-1900.",
      "product_quantity": "425 units",
      "distribution_pattern": "Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.",
      "openfda": {
        "k_number": [
          "K052519",
          "K153308",
          "K153303",
          "K040854",
          "K041231",
          "K031952",
          "K041068",
          "K031953",
          "K041817",
          "DEN030004"
        ],
        "registration_number": [
          "2029372",
          "3003268355",
          "2243471",
          "3032562",
          "2023365",
          "3007118747",
          "3002800697",
          "2245285",
          "3007361513"
        ],
        "fei_number": [
          "3002606748",
          "3003268355",
          "2243471",
          "2023365",
          "3007118747",
          "3002800697",
          "2245285",
          "1000306617",
          "3007361513"
        ],
        "device_name": "Elisa, Antibody, West Nile Virus",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3940",
        "device_class": "2"
      }
    }
  ]
}