{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Indianapolis",
      "address_1": "9115 Hague Rd",
      "reason_for_recall": "Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.",
      "address_2": "",
      "product_quantity": "537 meters total",
      "code_info": "Model/Catalog/Part Number: 05530199160",
      "center_classification_date": "20130624",
      "distribution_pattern": "Nationwide Distribution",
      "state": "IN",
      "product_description": "CoaguChek XS Pro System    The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time (\"PT\"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).",
      "report_date": "20130703",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "recall_number": "Z-1582-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "65246",
      "termination_date": "20140416",
      "more_code_info": "",
      "recall_initiation_date": "20130516",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}