{ "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": "139815", "product_res_number": "Z-0110-2016", "event_date_initiated": "2015-08-31", "event_date_posted": "2015-10-07", "recall_status": "Terminated", "event_date_terminated": "2016-05-16", "res_event_number": "72090", "product_code": "CDP", "k_numbers": [ "K960913" ], "product_description": "Access Free T3 Reagent Kit, P/N A13422\r\n\r\nThe Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.", "code_info": "Lot: 431433", "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": "Rula Melconian\n714-961-4295", "reason_for_recall": "Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.", "root_cause_description": "Under Investigation by firm", "action": "Beckman Coulter sent an \" Urgent Medical Device Recall\" letter dated August 31, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. \r\n\r\nThe letter informs the customers that some Access Free T3 reagent packs (p/n A13422) of lot 431433 were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center at http://ww.beckmancoulter.com; call (800) 854-3633 in US and Canada. Customers outside of US and Canada are instructed to contact their local Beckman Coulter representative.", "product_quantity": "16,648 units total (1874 units in US)", "distribution_pattern": "Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand and Viet Nam.", "openfda": { "k_number": [ "K893620", "K832164", "K873945", "K881373", "K803180", "K771220", "K880388", "K894200", "K842949", "K834348", "K962760", "K881214", "K974634", "K983434", "K961236", "K761305", "K791663", "K770918", "K780787", "K915792", "K840959", "K883479", "K870968", "K801843", "K772108", "K840222", "K963827", "K820763", "K802883", "K760078", "K812246", "K953160", "K880087", "K790960", "K001607", "K802470", "K860252", "K781284", "K960550", "K771142", "K952557", "K791317", "K770738", "K780499", "K852537", "K962355", "K955435", "K905261", "K973966", "K932608", "K940833", "K971779", "K905214", "K897001", "K904820", "K931600", "K772122", "K914467", "K831064", "K963127", "K905656", "K803261", "K831434", "K910737", "K772177", "K790908", "K934764", "K960412", "K842590", "K832469", "K905410", "K923258", "K983439", "K885195", "K791588", "K791375", "K963833", "K821725", "K770201", "K925436", "K903432", "K832353", "K781481", "K926345", "K964310", "K904098", "K801123", "K873737", "K932747", "K895840", "K960913", "K903433", "K811213", "K873858", "K894238", "K833853", "K991692", "K834049", "K792539", "K780018", "K840050", "K872191", "K800374", "K830808", "K770677", "K971270", "K922771", "K810211", "K770739", "K770648", "K812611", "K830980", "K864452", "K991311", "K801125", "K853703", "K965058", "K791232", "K790581", "K894993", "K963687", "K923571", "K883810", "K934517", "K800436", "K936229", "K896900", "K970016", "K760057", "K851676", "K962508", "K780492", "K810351", "K981824", "K923015", "K810798", "K812666", "K770520", "K780292", "K944808", "K991252", "K820251", "K771623", "K974027" ], "device_name": "Radioimmunoassay, Total Triiodothyronine", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1710", "device_class": "2", "registration_number": [ "2032682", "3017379203", "2245285", "3012963943", "3007118747", "9612316", "3011989923", "3017019647", "3007349751", "3004192065", "1319681", "8023018", "9680746", "3002809144", "3004434309", "2029372", "3005094123", "3009092698", "9610126", "2250051", "3009984016", "8031673", "2020726", "3003741796", "9610240", "1222302", "1827821", "2517506", "3017894300", "3007113174", "1219913", "1036362", "2032839", "8020888", "3007111389", "3005984081", "3002642396", "3005333358", "3002806944", "3033967997", "8010132", "2432235", "3009335633", "3006198300", "3000308930", "2122870", "3022178699", "3002800697", "3005529799", "1832216" ], "fei_number": [ "3017379203", "2245285", "3002808328", "3004185580", "3012963943", "3007118747", "3003952975", "3002807272", "3011989923", "3017019647", "3007349751", "3004192065", "3002809144", "3004434309", "3005094123", "3009092698", "2250051", "2967", "3009984016", "2020726", "3003741796", "1827821", "3002806559", "3017894300", "2517506", "3007113174", "1219913", "1000121039", "1000306617", "1036362", "1000136573", "3002806808", "3007111389", "3005984081", "3002642396", "1000206808", "3005333358", "3002806944", "3033967997", "3007019572", "2432235", "3002808212", "3009335633", "3006198300", "3000308930", "2122870", "3022178699", "3002800697", "3005529799", "1832216" ] } } ] }