{
  "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": [
    {
      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66239",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
      "address_2": "N/A",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution and Puerto Rico",
      "recall_number": "Z-0168-2014",
      "product_description": "COBAS INTEGRA 800 Analyzer with software 9864.C2  Cobas.  COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory     A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.",
      "product_quantity": "527 units",
      "reason_for_recall": "Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system.  Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof",
      "recall_initiation_date": "20130916",
      "center_classification_date": "20131105",
      "termination_date": "20150512",
      "report_date": "20131113",
      "code_info": "software version 9864.C2"
    }
  ]
}