{
  "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": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69964",
      "recalling_firm": "Alere San Diego, Inc.",
      "address_1": "9975 Summers Ridge Rd",
      "address_2": "N/A",
      "postal_code": "92121-2997",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.",
      "recall_number": "Z-0880-2015",
      "product_description": "Alere INRatio PT/INR Test Strips, Alere INRatio  PT/INR System Professional  - 0100071 Alere INRatio PT/INR Test Strips, Box of 12  - 0100139 Alere INRatio PT/INR Test Strips, Box of 48    The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box.    In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).",
      "product_quantity": "77,342 units (12 test strips/box) and 308,947 units (48 test strips/box)",
      "reason_for_recall": "In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.",
      "recall_initiation_date": "20141205",
      "center_classification_date": "20150103",
      "termination_date": "20170918",
      "report_date": "20150114",
      "code_info": "All lots of part numbers: 0100071 and 0100139.",
      "more_code_info": ""
    }
  ]
}