{
  "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": "San Diego",
      "address_1": "9975 Summers Ridge Rd",
      "reason_for_recall": "Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.",
      "address_2": "",
      "product_quantity": "",
      "code_info": "All Lots  All Serial Numbers",
      "center_classification_date": "20160819",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.",
      "state": "CA",
      "product_description": "Alere INRatio2 PT/INR Home Monitoring System  Model Number: 0200432, 0200433    Product Usage:  Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿2 PT/INR Home Monitoring System is not intended to be used for screening purposes.",
      "report_date": "20160831",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Alere San Diego, Inc.",
      "recall_number": "Z-2358-2016",
      "initial_firm_notification": "Press Release",
      "product_type": "Devices",
      "event_id": "74665",
      "termination_date": "20170720",
      "more_code_info": "",
      "recall_initiation_date": "20160711",
      "postal_code": "92121-2997",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}