{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "159896", "product_res_number": "Z-0310-2018", "event_date_initiated": "2017-11-06", "event_date_created": "2018-01-03", "recall_status": "Terminated", "event_date_terminated": "2019-11-04", "res_event_number": "78613", "product_code": "JJE", "k_numbers": [ "K060256" ], "product_description": "UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638.\n\nIn vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.", "code_info": "Serial/Lot Numbers: 801060 and 801061", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "additional_info_contact": "469-961-4941", "reason_for_recall": "Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.", "root_cause_description": "Device Design", "action": "An Urgent Medical Device Recall letter, dated November 6, 2017, were sent to the affected customers via mail. The letter identifies the affected device, the reason for recall, impact, and actions to be taken. The firm states that customers may continue to operate their system normally. Customers are instructed to contact Technical Support if a device on the Access 2 instrument needs alignment. The alignment tool is only to be used by the Beckman Coulter service personnel and Beckman Coulter trained biomedical engineers. A Beckman Coulter service rep will contact customers to schedule a service visit. Customers are to share this information with their staff and retain a copy of the letter. Customers are to respond via one of the ways identified. Beckman Coulter should be contacted with any questions regarding the notice.", "product_quantity": "2 units", "distribution_pattern": "Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K833448", "K930489", "K840868", "K760642", "K882914", "K890184", "K853699", "K950958", "K873617", "K780388", "K912024", "K840129", "K971761", "K813102", "K040958", "K863840", "K851638", "K942443", "K904219", "K963539", "K872104", "K882081", "K832584", "K843283", "K940289", "K884378", "K885289", "K772344", "K860080", "K802835", "K832115", "K853003", "K872813", "K946090", "K912844", "K832648", "K945135", "K792361", "K073370", "K860021", "K820888", "K933703", "K822465", "K885226", "K940810", "K823386", "K842773", "K853391", "K852133", "K112999", "K962235", "K844114", "K780083", "K841076", "K771345", "K843059", "K811919", "K831649", "K864849", "K920402", "K893547", "K854243", "K842500", "K780464", "K951189", "K922139", "K791296", "K833833", "K133519", "K965240", "K823762", "K884035", "K862818", "K840120", "K802609", "K830301", "K860748", "K882307", "K931786", "K915366", "K771245", "K110035", "K944028", "K834534", "K950915", "K790072", "K003721", "K894222", "K831518", "K915106", "K983345", "K803135", "K800572", "K885288", "K962231", "K882450", "K883321", "K942922", "K803267", "K893137", "K901346", "K945271", "K811194", "K051087", "K183375", "K962125", "K810596", "K872103", "K855196", "K970227", "K870833", "K843082", "K890927", "K874857", "K023764", "K882194", "K881495", "K943493", "K130276", "K843610", "K922072", "K901003", "K904220", "K800053", "K853621", "K895423", "K854025", "K923579", "K865105", "K063144", "K922220", "K791297", "K882559", "K840883", "K883209", "K830212", "K922680", "K961481", "K042169", "K923060", "K902689", "K810129", "K872302", "K870836", "K010500", "K860647", "K834521", "K944093", "K890183", "K953239", "K854936", "K833116", "K830318", "K820687", "K890929", "K872494", "K924084", "K852262", "K831477", "K810549", "K130915", "K873749", "K813160", "K883533", "K950353", "K910185", "K861055", "K840501", "K841916", "K873130", "K830762", "K893776", "K131554", "K931744", "K113253", "K881498", "K882451", "K890928", "K781528", "K801889", "K974651", "K833067", "K902336", "K933548", "K800085", "K921661", "K802320", "K882913", "K945566", "K863531", "K772319", "K841503", "K903071", "K942364", "K961274", "K781076", "K820118", "K883539", "K961142", "K872105", "K926060", "K821335", "K862235", "K002982", "K854138", "K782014", "K974779", "K770679" ], "pma_number": [ "P910007" ], "registration_number": [ "", "3003795116", "3003542872", "1827821", "3004102403", "3014353045", "2435505", "3008853996", "3042177088", "3008344661", "3042268054", "3008517993", "3002809144", "2016473", "3005748564", "2027969", "2432235", "1717966", "3009473156", "8021924", "9613959", "9610126", "3003637681", "3007135420", "8043379", "3012057020", "2026994", "3010324880", "9681753", "3000308930", "3003030793", "2020726", "3005622096", "3004145393", "3003917514", "3017098905", "3014643041", "2915796", "1000256526", "3006198300", "2030861", "9615037", "3014325803", "9610240", "1643621", "3011061417", "3005643513", "3033967997", "2431530", "9610942", "3007118747", "1319808", "9615837", "3005342322", "3034707949", "3014150341", "3007208259", "1000455123", "3010610113", "3011179004", "3014717638", "3005094123", "2050012", "3007500635", "9610566", "3013660430", "2221819", "8020888", "8031673", "3005509212", "2250051", "3009297077", "2032839", "3008576040", "9614698", "3008244372", "3007662974", "1616487", "3004529019", "2085064", "3003589956", "3006716639", "1931251", "3005655287", "3044473429", "3002895169", "3030234142", "3008425728", "9615754", "1220972", "3006677029", "1036362", "3003593973", "2122870", "3009518015", "1319809", "1217183", "3003741796", "3007603826", "3005529799", "3014607865", "3016438761", "9615056", "9614373", "3042244350", "3009984016", "3016244760", "2032900", "3021394862", "3012963943", "3008494306", "9610806", "3010421384", "3037000637", "3009711478", "3020978007", "3002642396", "1415939", "3005333358", "3027977508", "3023268435", "3003559191", "9680746", "3029973107", "3004493545", "3004434309", "1317202", "3002806944", "3004378326", "3017019647", "1832216", "3002889627", "3017548799", "9610529", "3009238284", "2245578", "3010031137", "2182595", "3017894300", "3035708936", "3030493719", "3010825766", "3012471076", "3023162659", "1219029", "3005748784", "1036223", "3003402518", "2050010", "2247288", "1181121", "9614673", "2523553", "3011989923", "1219913", "1319681", "3009156722", "3007111389", "3014840402", "8030478", "8020316", "9612296", "3004438098", "1319436", "3015969360", "1424235", "3012526002", "8023060", "3003268355", "3004973408", "3000148879", "2517506", "2915274", "3007361513" ], "fei_number": [ "1000119795", "", "3003795116", "3003542872", "1827821", "1000122044", "3004102403", "3014353045", "3008853996", "3042177088", "3008344661", "3042268054", "3008517993", "3002809144", "3005748564", "2432235", "1717966", "3009473156", "3004185580", "3003637681", "3007135420", "3012057020", "2026994", "3010324880", "3000308930", "3003030793", "2020726", "3005622096", "3004145393", "3003917514", "3017098905", "3014643041", "2915796", "1000256526", "3006198300", "3014325803", "3004445302", "1643621", "3011061417", "3005643513", "1000125787", "3033967997", "3003559576", "2431530", "3007118747", "1000305841", "3000303338", "3005342322", "3034707949", "3014150341", "3007019572", "3007208259", "3002807663", "3002806809", "1000455123", "1000186023", "3010610113", "3011179004", "3014717638", "3005094123", "3003261083", "2050012", "3007500635", "1000206808", "3013660430", "2221819", "3005509212", "2250051", "3009297077", "3008576040", "3008244372", "3007662974", "3002608770", "3007262384", "1616487", "3004529019", "3003589956", "3006716639", "3002808301", "1931251", "3005655287", "3044473429", "3002895169", "3030234142", "3008425728", "1220972", "3006677029", "1036362", "3003593973", "2122870", "3009518015", "3002808340", "1217183", "3003741796", "3007603826", "3005529799", "3002808382", "3014607865", "3016438761", "3003992026", "3042244350", "3009984016", "3016244760", "3021394862", "3012963943", "3008494306", "3010421384", "3037000637", "3009711478", "3020978007", "3002642396", "1415939", "3005333358", "1000120319", "3023268435", "1000305840", "3027977508", "1000125596", "3003559191", "3002806560", "3000215862", "3029973107", "3004493545", "3004434309", "1000136573", "3003413192", "1317202", "3002806944", "3004378326", "3001576181", "3002806559", "1000135102", "3017019647", "1832216", "3002485711", "3002889627", "3017548799", "3009238284", "2967", "2245578", "3010031137", "2182595", "3017894300", "3002807876", "3035708936", "3001075266", "3030493719", "3002808212", "3010825766", "3012471076", "3023162659", "1219029", "3005748784", "3008237827", "1036223", "3003402518", "2050010", "1181121", "2523553", "3011989923", "1219913", "3007111389", "3009156722", "3014840402", "3004438098", "3015969360", "3012526002", "3003268355", "3004973408", "3000148879", "2517506", "3001644026", "2915274", "3007361513" ], "device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2160", "device_class": "1" } } ] }