{
  "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": "86553 meters",
      "code_info": "Model/Catalog/Part Number: 04837975001 and 04625412160",
      "center_classification_date": "20130624",
      "distribution_pattern": "Nationwide Distribution",
      "state": "IN",
      "product_description": "CoaguChek XS System (HCP)    The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.",
      "report_date": "20130703",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "recall_number": "Z-1584-2013",
      "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"
    }
  ]
}