{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194047", "product_res_number": "Z-1321-2022", "event_date_initiated": "2022-05-18", "event_date_created": "2022-07-01", "recall_status": "Open, Classified", "res_event_number": "90286", "product_code": "CHL", "k_numbers": [ "K041874" ], "product_description": "ABL800 Flex Analyzer Model Numbers 393-800 and 393-801", "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", "firm_fei_number": "3002807968", "recalling_firm": "Radiometer Medical ApS", "address_1": "Akandevej 21 21 akandevej", "city": "Bronshoj", "country": "Denmark", "additional_info_contact": "Technical Support, Radiometer America Inc. \n800-736-0600 Ext. 1", "reason_for_recall": "There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.", "root_cause_description": "Software design", "action": "On May 20, 2022, Radiometer issued a \"Urgent: Medical Device Recall\" notification to affected consignees via: Email and FedEx 2nd day Mail. Radiometer ask consignees to take the following actions: \n\n1. For the affected micro measuring modes Radiometer kindly requests you to not use results for cNa+. The most efficient way to ensure this is to remove the parameter from the affected modes as per the procedures included within the letter. \n\n2. Please complete the Recall Response Form and return to your Radiometer representative (recall@radiometeramerica.com).", "product_quantity": "1489 analyzers", "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.", "openfda": { "k_number": [ "K940918", "K832779", "K122642", "K915087", "K840468", "K914560", "K012478", "K831021", "K961161", "K884143", "K823750", "K860057", "K834601", "K771253", "K160153", "K050423", "K221900", "K974526", "K863880", "K820597", "K760969", "K141907", "K123748", "K252207", "K760229", "K943643", "K831015", "K895181", "K812552", "K781968", "K935069", "K982928", "K852790", "K992859", "K944089", "K772307", "K963800", "K992834", "K942616", "K961657", "K831019", "K122539", "K831013", "K833534", "K954612", "K961335", "K913927", "K935655", "K973367", "K022746", "K110648", "K853405", "K831012", "K935121", "K111188", "K840843", "K844781", "K223608", "K820744", "K002613", "K953935", "K882209", "K831025", "K230285", "K093280", "K962021", "K160412", "K980130", "K991417", "K021515", "K014295", "K023567", "K840300", "K771822", "K864445", "K800757", "K000103", "K051804", "K936203", "K131988", "K932642", "K031560", "K871397", "K982277", "K904513", "K002290", "K133407", "K111897", "K760748", "K110416", "K865036", "K945240", "K990092", "K041874", "K831017", "K244014", "K980523", "K936081", "K943882", "K884267", "K831379", "K853840", "K063376", "K200986", "K223857", "K800224", "K873577", "K924758", "K832981", "K061974", "K002738", "K173403", "K043218", "K203790", "K831010", "K850360", "K833536", "K970710", "K891578", "K882941", "K946206", "K831020", "K922631", "K020297", "K904188", "K934907", "K844295", "K810724", "K823570", "K831023", "K771147", "K013729", "K841609", "K192240", "K831024", "K122729", "K100777", "K211559", "K821483", "K200107", "K130144", "K943570", "K012058", "K173797", "K854608", "K142220", "K200492", "K935830", "K974396", "K831018", "K922922", "K151982", "K954482", "K810308", "K240998", "K955793", "K980991", "K770736", "K994346", "K142898", "K890827", "K151978", "K831016", "K792230", "K120197", "K852676", "K842519", "K812090", "K895317", "K903965", "K993789", "K131703", "K080370", "K902267", "K193246", "K963964", "K151856", "K881188", "K954711", "K780716", "K924497", "K800271", "K984384", "K812623", "K914166", "K131126", "K021713", "K813517" ], "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1120", "device_class": "2", "registration_number": [ "9610633", "1222035", "1217183", "1220972", "3005643513", "3004959793", "3002637618", "1181121", "2050012", "8030478", "1000455123", "3012817228", "3003971136", "1717966", "3007490412", "3012104670", "1036362", "3014506106", "2431530", "2432235", "3003795116", "3015997711", "1219029", "3006198300", "3037000637", "3002807968", "3007662974", "3004102403", "1219913", "1220649", "2245578", "3023162659", "3013513377", "9610126" ], "fei_number": [ "1222035", "1217183", "3002806693", "1220972", "3002806559", "3005643513", "3004959793", "3002637618", "1181121", "2050012", "1000455123", "3012817228", "3003971136", "1717966", "3007490412", "3012104670", "1036362", "3014506106", "2431530", "2432235", "3003795116", "3015997711", "1219029", "3006198300", "3037000637", "3002807968", "3007662974", "3004102403", "3001576181", "1219913", "1220649", "2245578", "3023162659", "3013513377" ] } } ] }