{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "180206", "product_res_number": "Z-1836-2020", "event_date_initiated": "2020-03-06", "event_date_created": "2020-05-01", "recall_status": "Open, Classified", "res_event_number": "85166", "product_code": "CHL", "k_numbers": [ "K041874" ], "product_description": "ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004", "code_info": "Serial Numbers: 902-754R2692N002 and 902-754R2692N001", "firm_fei_number": "3002807968", "recalling_firm": "Radiometer Medical ApS", "address_1": "Akandevej 21 21 akandevej", "city": "Bronshoj", "country": "Denmark", "additional_info_contact": "Technical Support\n800-7360600 Ext. 1", "reason_for_recall": "Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.", "root_cause_description": "Component design/selection", "action": "On 3/5/2020 a \"Urgent: Medical device Recall\" letter was hand delivered to effective consignees. In addition to providing information on the recall products, the customer notification as consignees to take the following actions:\n\nSolution provided by Radiometer:\n1. Your Radiometer representative will exchange the power supply of your ABL800 analyzer at the earliest convenience.\n\nYour Actions:\n1. Cease using the affected ABL800 analyzer and put it on quarantine.\n2. Shut down the affected ABL800 analyzer and disconnect the power cord.\n3. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative\n4. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST.", "product_quantity": "2 units", "distribution_pattern": "US: in the state of California", "openfda": { "k_number": [ "K061974", "K974526", "K122729", "K944089", "K936081", "K831015", "K820744", "K953935", "K002738", "K022746", "K832981", "K842519", "K936203", "K994346", "K151978", "K781968", "K123748", "K813517", "K080370", "K223857", "K854608", "K991417", "K942616", "K141907", "K002290", "K914560", "K760748", "K160153", "K963800", "K890827", "K240998", "K955793", "K110416", "K831023", "K881188", "K844781", "K940918", "K961161", "K840843", "K771253", "K945240", "K810308", "K800224", "K133407", "K151856", "K904188", "K131126", "K771147", "K934907", "K151982", "K961657", "K850360", "K200492", "K831024", "K780716", "K200107", "K974396", "K800271", "K833534", "K943882", "K993789", "K792230", "K221900", "K831017", "K093280", "K954711", "K031560", "K853405", "K970710", "K853840", "K882941", "K831025", "K831010", "K833536", "K142898", "K023567", "K946206", "K935830", "K192240", "K992859", "K884267", "K252207", "K831020", "K821483", "K831021", "K914166", "K982928", "K014295", "K963964", "K050423", "K973367", "K904513", "K834601", "K810724", "K823570", "K932642", "K110648", "K961335", "K954612", "K820597", "K852790", "K980991", "K984384", "K000103", "K120197", "K812623", "K891578", "K865036", "K131988", "K943643", "K864445", "K913927", "K954482", "K173797", "K812090", "K230285", "K200986", "K211559", "K831012", "K831016", "K130144", "K823750", "K193246", "K063376", "K244014", "K935069", "K831379", "K142220", "K915087", "K902267", "K770736", "K980523", "K844295", "K043218", "K122642", "K871397", "K980130", "K012478", "K831018", "K935655", "K943570", "K122539", "K992834", "K002613", "K131703", "K800757", "K051804", "K760229", "K922631", "K882209", "K860057", "K772307", "K903965", "K223608", "K884143", "K863880", "K895181", "K962021", "K831019", "K832779", "K982277", "K840300", "K111188", "K111897", "K812552", "K020297", "K924758", "K935121", "K012058", "K100777", "K160412", "K021713", "K990092", "K760969", "K041874", "K203790", "K895317", "K013729", "K831013", "K021515", "K873577", "K924497", "K922922", "K173403", "K841609", "K840468", "K852676", "K771822" ], "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": [ "1219913", "3005643513", "3015997711", "2245578", "3007662974", "3002637618", "3012104670", "3002807968", "1220649", "2432235", "1220972", "1000455123", "1717966", "9610633", "8030478", "3014506106", "1217183", "1036362", "3012817228", "2050012", "3023162659", "3013513377", "3004959793", "3004102403", "1222035", "9610126", "3006198300", "2431530", "1219029", "3037000637", "3003795116", "3003971136", "1181121", "3007490412" ], "fei_number": [ "3002806559", "1219913", "3005643513", "3015997711", "2245578", "3007662974", "3002637618", "3012104670", "3002807968", "1220649", "2432235", "1220972", "1000455123", "1717966", "3002806693", "3014506106", "3001576181", "1217183", "1036362", "3012817228", "2050012", "3023162659", "3013513377", "3004959793", "3004102403", "1222035", "3006198300", "2431530", "1219029", "3037000637", "3003795116", "3003971136", "1181121", "3007490412" ] } } ] }