{
  "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": "67549",
      "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": "Worldwide Distribution - USA nationwide including PR and the country of  Guam.",
      "recall_number": "Z-1315-2014",
      "product_description": "Omni Micro-electrode/reference electrode for cobas b221 analyzer,  Model/Catalog/Part Number:  03111873180 as a part of the following systems:  1. 03337103001, cobas b 221<1>Roche OMNI S1 system    2. 03337111001, cobas b 221<2>Roche OMNI S2 system    3. 03337154001,cobas b 221<6>Roche OMNI S6 system    4. 03337138001, cobas b 221<4>Roche OMNI S4 system    Product Usage:  Usage:  Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin",
      "product_quantity": "N/A",
      "reason_for_recall": "Reference electrode  used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results.  Other Ion parameters are not affected.",
      "recall_initiation_date": "20140228",
      "center_classification_date": "20140401",
      "termination_date": "20180110",
      "report_date": "20140409",
      "code_info": "all serial numbers"
    }
  ]
}