{
  "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-0881-2015",
      "product_description": "INRatio Monitors  - 0100004 Alere INRatio PT/INR System Professional  - 0100007 INRatio Prothrombin Time (PT) Monitoring System  - 0100137 Alere INRatio Replacement Monitor    The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card.  None of the components, except for the lancets, are sterile.    In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.",
      "product_quantity": "231,967 Test Systems including Monitors",
      "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: 0100004, 0100007, and 0100137.",
      "more_code_info": ""
    }
  ]
}