{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "159600", "product_res_number": "Z-0231-2018", "event_date_initiated": "2017-10-24", "event_date_created": "2017-12-08", "recall_status": "Terminated", "event_date_terminated": "2023-10-10", "res_event_number": "78445", "product_code": "CHL", "k_numbers": [ "K041874" ], "product_description": "ABL800 analyzer with FLEXQ module.\n\nDevice intended for in vitro testing of samples of whole blood for the parameters 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. It is also used for in vitro testing of pleura samples for the pH parameter", "code_info": "All serial numbers", "firm_fei_number": "3010420736", "recalling_firm": "Radiometer America Inc", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "additional_info_contact": "800-736-0600", "reason_for_recall": "Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.", "root_cause_description": "Software in the Use Environment", "action": "Customer were notified via letter using FedEx tracking on approximately October 24, 2017. Instructions included verification that the test results and the patient and demographic information matches, that Radiometer America is working to improve the software to remove the possibility of the code being misinterpreted, and to notify customers if the product has been further distributed. For further questions, please call (800) 736-0600.", "product_quantity": "1,749 analyzers", "distribution_pattern": "USA (nationwide) to: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Distributed internationally to Canada.", "openfda": { "k_number": [ "K990092", "K771253", "K854608", "K770736", "K833534", "K831025", "K962021", "K934907", "K844295", "K974396", "K932642", "K961335", "K812090", "K884267", "K771147", "K200986", "K994346", "K831012", "K760229", "K240998", "K832779", "K935655", "K002613", "K882941", "K051804", "K810724", "K842519", "K200492", "K110416", "K110648", "K852676", "K924497", "K173403", "K884143", "K151978", "K812552", "K122539", "K813517", "K993789", "K823570", "K831015", "K940918", "K050423", "K935121", "K002290", "K820744", "K223857", "K904513", "K954612", "K151982", "K122642", "K833536", "K221900", "K173797", "K021713", "K820597", "K973367", "K936081", "K914166", "K881188", "K000103", "K133407", "K865036", "K974526", "K841609", "K831020", "K945240", "K831379", "K013729", "K853840", "K873577", "K943643", "K924758", "K151856", "K871397", "K922922", "K902267", "K041874", "K021515", "K020297", "K111897", "K955793", "K980523", "K942616", "K760969", "K963964", "K043218", "K992834", "K890827", "K844781", "K122729", "K831019", "K831018", "K831010", "K230285", "K953935", "K831013", "K863880", "K935830", "K831021", "K160153", "K904188", "K014295", "K142898", "K991417", "K992859", "K100777", "K944089", "K834601", "K022746", "K895317", "K772307", "K831016", "K831017", "K961161", "K111188", "K760748", "K891578", "K192240", "K131126", "K943882", "K780716", "K012058", "K840843", "K800757", "K821483", "K012478", "K914560", "K810308", "K131988", "K850360", "K023567", "K852790", "K895181", "K080370", "K131703", "K970710", "K980991", "K831023", "K946206", "K963800", "K031560", "K203790", "K961657", "K913927", "K984384", "K853405", "K130144", "K141907", "K936203", "K832981", "K840300", "K860057", "K093280", "K200107", "K142220", "K922631", "K211559", "K831024", "K982277", "K252207", "K980130", "K882209", "K800224", "K792230", "K864445", "K812623", "K954711", "K954482", "K943570", "K063376", "K840468", "K915087", "K903965", "K061974", "K160412", "K935069", "K223608", "K002738", "K823750", "K800271", "K193246", "K123748", "K244014", "K120197", "K771822", "K781968", "K982928" ], "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": [ "2050012", "1220972", "3004959793", "3013513377", "3004102403", "1219029", "3005643513", "3002807968", "9610633", "8030478", "9610126", "3007490412", "1217183", "1717966", "3023162659", "1220649", "1219913", "3037000637", "3003795116", "1036362", "3012104670", "1222035", "3002637618", "2245578", "2431530", "2432235", "1181121", "3007662974", "1000455123", "3015997711", "3012817228", "3006198300", "3014506106", "3003971136" ], "fei_number": [ "2050012", "1220972", "3004959793", "3013513377", "3001576181", "3004102403", "1219029", "3005643513", "3002807968", "3002806693", "3007490412", "1217183", "1717966", "3002806559", "3023162659", "1220649", "1219913", "3037000637", "3003795116", "1036362", "3012104670", "1222035", "3002637618", "2245578", "2431530", "2432235", "1181121", "3007662974", "1000455123", "3015997711", "3012817228", "3006198300", "3014506106", "3003971136" ] } } ] }