{
  "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 Systems (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": "INRatio Prothrombin Time (PT) Monitoring System  Model Number: 0100007     Product Usage:  The INRatio Prothrombin Time Monitoring 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 cause coagulation to begin. The test strip area on the test strip is separated into three channels, each of which contains electrodes for detection of the blood clot. One channel contains the reagents to perform the Prothrombin time test on the blood sample. The other two channels contain the reagents. to perfom the Prothrombin time test on the blood sample. The other two channels contain the reagents to run control tests. No external quality control test are required for the INRatio System. The meter monitors the reactions, and calculates the PT and INR for the blood sample, which are reported on the display. If the control results are not within a set range, it indicates a problem with the test and an error message is reported on the display instead of a result.",
      "report_date": "20160831",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Alere San Diego, Inc.",
      "recall_number": "Z-2355-2016",
      "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"
    }
  ]
}