{
  "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": "cobas p 512 Pre-Analytical Instrument  calculator/data processing module, for clinical use    Product Usage:  The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnostic laboratories.",
      "report_date": "20161102",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "recall_number": "Z-0107-2017",
      "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"
    }
  ]
}