{
  "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": "Indianapolis",
      "address_1": "9115 Hague Rd",
      "reason_for_recall": "Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzer\u0019s sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.",
      "address_2": "",
      "product_quantity": "9014 in total",
      "code_info": "Not applicable",
      "center_classification_date": "20161025",
      "distribution_pattern": "US Nationwide Distribution",
      "state": "IN",
      "product_description": "Roche/Hitachi MODULAR Analytics Combination Systems  Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer    Product Usage:  The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.",
      "report_date": "20161102",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "recall_number": "Z-0094-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75186",
      "termination_date": "20170605",
      "more_code_info": "",
      "recall_initiation_date": "20160715",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}