{
  "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 Test Strips. 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 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 INRatio/ INRatio2 PT/INR Test Strips  Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7    Product Usage:  The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for use outside the body (in vitro diagnostic use). The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio/INRatio2 PT/INR 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-2362-2016",
      "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"
    }
  ]
}