{
  "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": "cobas c 111 analyzers (catalog numbers 04777433001 and  04528778001) with software versions up to and including 4.20 may encounter the following alarm:  \u001c7002: 108000572, A software error occurred.\u001d This alarm is generated due to a measurement timing  error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run  restarts.  If a used cuvette is used again result of the test(s) will be erroneous.  These erroneous results may not be flagged.  Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic  decisions. The medical risk depends on the parameter.",
      "address_2": "",
      "product_quantity": "139",
      "code_info": "04777433001 \u0013 Cobas c111 with ISE  04528778001 \u0013 Cobas c111 without ISE    cobas c 111 analyzers (catalog numbers 04777433001 and  04528778001) with software versions up to and including 4.20",
      "center_classification_date": "20161109",
      "distribution_pattern": "US Nationwide Distribution",
      "state": "IN",
      "product_description": "Roche COBAS INTEGRA c111  Analyzer, Chemistry (Photometric, Discrete), for clinical use    Product Usage:  The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.",
      "report_date": "20161116",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "recall_number": "Z-0387-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75357",
      "termination_date": "20170721",
      "more_code_info": "",
      "recall_initiation_date": "20160927",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}