{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Scarborough",
      "address_1": "10 Southgate Rd",
      "reason_for_recall": "High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.",
      "address_2": "",
      "product_quantity": "213 kits plus 3 - evaluation use only kits",
      "code_info": "PN 425-024, LN 0072633 (United States Distribution) and PN 425-000, LN 0073888 (distributed in Hong Kong, Singapore - evaluation use only)",
      "center_classification_date": "20150527",
      "distribution_pattern": "Worldwide Distribution - US  Nationwide in the states of AL CA CT FL IA ID IL IN KY LA MD MO MS NC NE NJ OH PA SC TN TX and the countries of: Hong Kong and Singapore.",
      "state": "ME",
      "product_description": "Alere i Influenza A & B    Product Usage:  The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.",
      "report_date": "20150603",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Alere Scarborough, Inc. dba Binax, Inc.",
      "recall_number": "Z-1677-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "71059",
      "termination_date": "20160114",
      "more_code_info": "",
      "recall_initiation_date": "20150422",
      "postal_code": "04074-8303",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}