{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bronshoj",
      "state": "N/A",
      "country": "Denmark",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85168",
      "recalling_firm": "Radiometer Medical ApS",
      "address_1": "Akandevej 21",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and countries of Canada, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Croatia, Russia, Norway.",
      "recall_number": "Z-1684-2020",
      "product_description": "ABL800 FLEX, model number/UDI 393-800/0570  In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF)   In vitro testing of samples of expired air for the parameters pO2 and pCO2   In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:",
      "product_quantity": "3,656 units",
      "reason_for_recall": "Analyzer's barcode reader misinterprets the contents of barcode  label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment",
      "recall_initiation_date": "20200310",
      "center_classification_date": "20200408",
      "termination_date": "20221031",
      "report_date": "20200415",
      "code_info": "Software versions below 6.19"
    }
  ]
}