{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cypress",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63387",
      "recalling_firm": "Focus Diagnostics Inc",
      "address_1": "11331 Valley View St",
      "address_2": "N/A",
      "postal_code": "90630-5366",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.",
      "recall_number": "Z-0182-2013",
      "product_description": "West Nile Virus IgG DxSelect\" kit 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.    510(k) No. K031953    The 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\u0019 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.",
      "product_quantity": "425 units",
      "reason_for_recall": "The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a  higher false positive rate.",
      "recall_initiation_date": "20121003",
      "center_classification_date": "20121031",
      "termination_date": "20121204",
      "report_date": "20121107",
      "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.",
      "more_code_info": ""
    }
  ]
}