{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "113592", "product_res_number": "Z-0195-2013", "event_date_initiated": "2010-01-06", "event_date_posted": "2012-11-05", "recall_status": "Terminated", "event_date_terminated": "2012-11-05", "res_event_number": "63368", "product_code": "CHL", "k_numbers": [ "K080370" ], "product_description": "ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35).\n\nThe ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is 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", "code_info": "Serial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34.", "firm_fei_number": "2027541", "recalling_firm": "Sendx Medical Inc", "address_1": "1945 Palomar Oaks Way", "city": "Carlsbad", "state": "CA", "postal_code": "92011-1300", "additional_info_contact": "760-603-6300", "reason_for_recall": "The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.", "root_cause_description": "Software design", "action": "SenDx Medical sent a recall letter to all their foreign customers on January 6, 2010, to informed them of the ABL80 FLEX CO-OX recall via the Radiometer Field Action Notification (FAN) system. The Field Action Notes informed the customers of the problem identified and the action to be taken. Customers were instructed to submit confirmation fax#1 to confirm that the customer letter has been distributed to all ABL80 CO-OX customers by January 31, 2010. Customers were instructed to submit confirmation fax #2 to confirm that all ABL80 CO-OX analyzers have been upgraded to version 1.35 by 6/30/10.\n\nIn the U.S., the customer was provided with a software upgrade CD along with a letter advising them to the issues associated with the recall. Customers with questions were instructed to contact TechLine at (800) 736-0600 opt 2.", "product_quantity": "767 units", "distribution_pattern": "Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic.", "openfda": { "k_number": [ "K820597", "K895181", "K860057", "K945240", "K954711", "K063376", "K832779", "K041874", "K012478", "K013729", "K043218", "K865036", "K991417", "K993789", "K954612", "K992859", "K891578", "K000103", "K131988", "K193246", "K935655", "K200492", "K953935", "K936081", "K093280", "K904513", "K771253", "K890827", "K914560", "K223857", "K973367", "K023567", "K031560", "K123748", "K982928", "K141907", "K240998", "K122539", "K760229", "K131703", "K221900", "K122642", "K812552", "K142898", "K131126", "K961657", "K935121", "K771822", "K840300", "K844781", "K160153", "K211559", "K252207", "K020297", "K800224", "K944089", "K014295", "K854608", "K130144", "K963964", "K831012", "K864445", "K160412", "K943643", "K853840", "K963800", "K831010", "K955793", "K810724", "K792230", "K841609", "K002290", "K831020", "K902267", "K022746", "K820744", "K760748", "K151978", "K833536", "K100777", "K200107", "K980991", "K940918", "K012058", "K111188", "K770736", "K961161", "K935830", "K980130", "K831019", "K884267", "K863880", "K922922", "K780716", "K831016", "K871397", "K120197", "K852676", "K813517", "K924758", "K831379", "K954482", "K002613", "K821483", "K882941", "K934907", "K990092", "K831021", "K173797", "K840468", "K936203", "K913927", "K002738", "K772307", "K882209", "K812090", "K831015", "K151982", "K133407", "K021515", "K771147", "K850360", "K980523", "K974396", "K223608", "K823570", "K914166", "K812623", "K924497", "K110648", "K853405", "K842519", "K904188", "K833534", "K935069", "K974526", "K840843", "K051804", "K832981", "K831024", "K173403", "K831025", "K984384", "K760969", "K831013", "K200986", "K800757", "K884143", "K192240", "K994346", "K823750", "K943570", "K932642", "K244014", "K961335", "K852790", "K881188", "K831018", "K873577", "K050423", "K946206", "K970710", "K922631", "K942616", "K061974", "K915087", "K895317", "K831023", "K110416", "K943882", "K021713", "K834601", "K810308", "K203790", "K122729", "K800271", "K142220", "K982277", "K080370", "K992834", "K151856", "K111897", "K781968", "K962021", "K903965", "K844295", "K831017", "K230285" ], "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": [ "2432235", "1219029", "1220972", "9610633", "3002807968", "2050012", "3015997711", "3006198300", "3012104670", "3005643513", "1219913", "2431530", "3037000637", "3002637618", "3014506106", "1222035", "1036362", "9610126", "3007490412", "3007662974", "1000455123", "1181121", "2245578", "3013513377", "3023162659", "1217183", "8030478", "3004102403", "3012817228", "1717966", "1220649", "3003971136", "3004959793", "3003795116" ], "fei_number": [ "2432235", "1219029", "3002806559", "1220972", "3002807968", "2050012", "3015997711", "3006198300", "3012104670", "3005643513", "1219913", "2431530", "3037000637", "3002637618", "3014506106", "1222035", "1036362", "3001576181", "3007490412", "3007662974", "1000455123", "1181121", "2245578", "3013513377", "3023162659", "3002806693", "1217183", "3004102403", "3012817228", "1717966", "1220649", "3003971136", "3004959793", "3003795116" ] } } ] }