{
  "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": [
    {
      "status": "Terminated",
      "city": "Scarborough",
      "state": "ME",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71585",
      "recalling_firm": "Alere Scarborough, Inc. dba Binax, Inc.",
      "address_1": "10 Southgate Rd",
      "address_2": "N/A",
      "postal_code": "04074-8303",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.",
      "recall_number": "Z-2095-2015",
      "product_description": "Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024  The Alere\" i Influenza A & 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.",
      "product_quantity": "257 Kits",
      "reason_for_recall": "Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit",
      "recall_initiation_date": "20150626",
      "center_classification_date": "20150716",
      "termination_date": "20150915",
      "report_date": "20150722",
      "code_info": "Lot Number 0073853 (US distribution only)",
      "more_code_info": ""
    }
  ]
}