{ "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": "2026-10-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222446", "product_res_number": "Z-0190-2027", "event_date_initiated": "2026-08-18", "event_date_posted": "2026-10-15", "recall_status": "Open, Classified", "res_event_number": "99772", "product_code": "CHL", "k_numbers": [ "K041874" ], "product_description": "The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.", "code_info": "UDI-DI: 05700693930923, 05700693930909\nSoftware versions 3.6 and lower.\nABL90 FLEX PLUS Instructions for Use versions prior to: 996-223, Version: 202606O. \nABL90 FLEX Instructions for Use versions prior to: 996-189, Version: 202606L", "firm_fei_number": "3002807968", "recalling_firm": "Radiometer Medical ApS", "address_1": "Akandevej 21 21 akandevej", "city": "Bronshoj", "country": "Denmark", "additional_info_contact": "Technical Support\n800-736-0600", "reason_for_recall": "In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.", "root_cause_description": "No Marketing Application", "action": "On 8/18/2026, correction notices were mailed or emailed to customers who were asked to take the actions listed in the correction notice. The firm updated intended use and instructions for use. In addition, the firm is developing an updated software version that will modify the analyzer configuration in accordance with the updated FDA clearances.\n\nCustomers are asked to do the following:\n1) Implement the requested changes to the setup of your analyzer(s) as stated in the correction letter.\n2) Review the changes to the labeling for the analyzers as stated in the updated Instructions for Use.\n3) Complete and return the Recall Response Form via email to recall@radiometeramerica.com\n4) If you are not the end user of the affected product, please ensure that this letter is distributed to the end user.\n\nIf you have any questions, contact the firm at 1-800-736-0600 option 1, Monday - Friday 9am to 7pm (EST)", "product_quantity": "5395", "distribution_pattern": "US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL, TX, GA, NC, PA, SC, MI, OK, WI, AR, MN, OR, UT, WA, SD, IN, TN, AZ, NE, WY, KY, AL, AK, ID, NJ, DE, MT, CT, MS, MO, VT, WV, IA, MD, KS, DC, NV, VA, NM, NH, ND, ME, HI, RI.", "openfda": { "k_number": [ "K031560", "K940918", "K080370", "K935121", "K043218", "K842519", "K963800", "K821483", "K203790", "K863880", "K800757", "K881188", "K831025", "K831018", "K780716", "K051804", "K850360", "K852790", "K852676", "K864445", "K252207", "K200492", "K954612", "K772307", "K023567", "K800224", "K021713", "K984384", "K831021", "K924758", "K022746", "K160412", "K193246", "K760229", "K982277", "K970710", "K200986", "K936203", "K130144", "K974396", "K823570", "K882941", "K792230", "K041874", "K891578", "K111897", "K853840", "K840300", "K831012", "K151982", "K844295", "K230285", "K913927", "K820744", "K943570", "K200107", "K770736", "K771253", "K953935", "K812623", "K831379", "K020297", "K002290", "K812090", "K922631", "K123748", "K834601", "K173797", "K211559", "K991417", "K820597", "K962021", "K945240", "K943643", "K131988", "K012058", "K823750", "K240998", "K061974", "K980130", "K993789", "K002738", "K895317", "K813517", "K895181", "K992859", "K831023", "K865036", "K914166", "K771822", "K961161", "K831013", "K973367", "K884267", "K955793", "K903965", "K833536", "K050423", "K221900", "K021515", "K151978", "K942616", "K002613", "K904513", "K141907", "K142220", "K980523", "K934907", "K873577", "K142898", "K853405", "K974526", "K961657", "K831019", "K831024", "K122539", "K810308", "K922922", "K120197", "K131703", "K961335", "K781968", "K840468", "K924497", "K840843", "K904188", "K946206", "K151856", "K122642", "K833534", "K013729", "K014295", "K963964", "K954711", "K992834", "K812552", "K915087", "K882209", "K935830", "K173403", "K982928", "K944089", "K831015", "K131126", "K831017", "K832779", "K914560", "K223608", "K994346", "K884143", "K093280", "K980991", "K831020", "K890827", "K932642", "K871397", "K244014", "K902267", "K133407", "K831010", "K110416", "K760748", "K000103", "K192240", "K841609", "K063376", "K122729", "K831016", "K844781", "K111188", "K771147", "K854608", "K012478", "K800271", "K110648", "K935069", "K760969", "K990092", "K935655", "K223857", "K936081", "K100777", "K954482", "K943882", "K810724", "K860057", "K832981", "K160153" ], "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": [ "9610126", "3015997711", "2245578", "1217183", "1222035", "3004102403", "1219913", "3004959793", "3014506106", "1036362", "2431530", "1717966", "9610633", "3007490412", "3003795116", "3006198300", "1220649", "8030478", "3005643513", "3003971136", "3002807968", "1000455123", "3012104670", "1220972", "3002637618", "3012817228", "2050012", "1219029", "3013513377", "3023162659", "3007662974", "1181121", "3037000637", "2432235" ], "fei_number": [ "3015997711", "2245578", "1217183", "1222035", "3004102403", "1219913", "3004959793", "3014506106", "1036362", "2431530", "1717966", "3007490412", "3003795116", "3006198300", "1220649", "3002806559", "3005643513", "3003971136", "3002807968", "1000455123", "3012104670", "1220972", "3002637618", "3012817228", "3001576181", "3002806693", "2050012", "1219029", "3013513377", "3023162659", "3007662974", "1181121", "3037000637", "2432235" ] } } ] }