{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bronshoj",
      "state": "N/A",
      "country": "Denmark",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90286",
      "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 AR, AZ, 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, \tNJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of  Bermuda, Canada, Italy, Norway, Austria, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe, China, Croatia, Denmark, Iceland, Germany, Spain, Portugal, India, Brunei, Japan, United Kingdom, Ireland, Russia, Hungary, Australia, New Zealand, Tokelau, Switzerland, France, Czech Republic, Slovakia, South Africa, Botswana, Namibia, Poland, Turkey, Sweden, Finland, Estonia, Kazakhstan, Malaysia, Hong Kong, Mexico, South Korea, Singapore.",
      "recall_number": "Z-1321-2022",
      "product_description": "ABL800 Flex Analyzer Model Numbers 393-800 and 393-801",
      "product_quantity": "1489 analyzers",
      "reason_for_recall": "There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.",
      "recall_initiation_date": "20220518",
      "center_classification_date": "20220701",
      "report_date": "20220713",
      "code_info": "All ABL800 Flex Analyzers containing software versions below V6.19 MR2;  UDI/DI ABL810, 820, and 830, ABL805, ABL815, ABL825, ABL835: 05700693938004 ;  UDI/DI ABL817, ABL827, ABL837: 05700693938011",
      "more_code_info": ""
    }
  ]
}