{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78097",
      "recalling_firm": "Radiometer America Inc",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "N/A",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain  France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.",
      "recall_number": "Z-3237-2017",
      "product_description": "AutoCheck5+, Level 2, specifically designed for Radiometer America\u0019s blood gas analyzers  The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers",
      "product_quantity": "1669 Boxes",
      "reason_for_recall": "Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2.  A defective QC ampoule will for:  \" pCO2 give a result close to or just outside of the low end of the control range. (4.92 \u0013 5.85 kPa or 36.9 \u0013 46.9 mmHg)  \" pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)",
      "recall_initiation_date": "20170907",
      "center_classification_date": "20170929",
      "termination_date": "20190801",
      "report_date": "20171011",
      "code_info": "S7745 Lot R0698",
      "more_code_info": ""
    }
  ]
}