{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "130168", "product_res_number": "Z-0474-2015", "event_date_initiated": "2014-09-11", "event_date_posted": "2014-12-03", "recall_status": "Terminated", "event_date_terminated": "2016-12-23", "res_event_number": "69289", "product_code": "CDP", "k_numbers": [ "K983439" ], "product_description": "ARCHITECT Total T3 Reagent Kit (7K64) consists of: \n\n- 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. \n\n- 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300.\n\nThe ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.", "code_info": "Product List Numbers, Lot Numbers, and Expiration Dates:   1) List Number: 7K64-20, Lot Number 38901UI00, Expires: 29-Jan-15;  2) List Number: 7K64-25; Lot Number 38901UI01, Expires: 29-Jan-15", "firm_fei_number": "3005094123", "recalling_firm": "Abbott Ireland Diagnostics Division", "address_1": "Lisnamuck", "city": "Lisnamuck Co. Longford", "country": "Ireland", "additional_info_contact": "Customer Service\n877-4222688", "reason_for_recall": "17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected.", "root_cause_description": "Employee error", "action": "Abbott sent an Product Recall letter dated September 11, 2014, to all direct accounts (customers). The letters included instructions for customers to: 1) Discontinue use of and destroy any remaining inventory according to your laboratory procedures; 2) follow your laboratory protocol regarding the need for review of previously reported patient results; 3) replacement material is available; for ordering, please order through your normal ordering process; and, 4) if you have forwarded any of the affected lots to another laboratory, please provide them with a copy of this communication. \n\nCustomers or healthcare providers with questions can contact Customer Service at 1-877-422-2688 (24 hours a day, 7 days a week).", "product_quantity": "7,415 kits", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL , AR , AZ , CA , CT , FL , GA , IL , IN , KS , LA , MA , MD , MI , MN , MO , MS , MT , NC , NJ , NV , NY , OH , OK , PA , SC , SD , TN , TX , UT , VA , WA , WI and WV., and the countries of : Andorra , Angola , Argentina , Armenia , Austria , Azerbaijan , Bangladesh , Barbados , Belarus , Belgium , Bosnia & Herzegovina , Brazil , Burkina Faso , Canada , Cayman Islands , Chile , China , Colombia , Costa Rica , Croatia , Czech Republic , Ecuador , Egypt , El Salvador , Ethopia , Georgia , Germany , Greece , Greenland , Guatemala , Honduras , Hong Kong , India , Indonesia , Iran , Ireland , Israel , Italy , Jamaica , Japan , Kazakhstan , Kenya , Korea , Kuwait , Latvia , Lebanon , Libya , Malaysia , Mexico , Moldova , Montenegro , Oman , Pakistan , Gaza & Jericho , Panama , Paraguay , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia , Saudi Arabia , Serbia , Singapore , Slovakia , Spain , Sri Lanka. , Switzerland , Taiwan , Tajikistan , Thailand , The Netherlands , Trinidad & Tobago , Turkey , Ukraine ,United Arab Emirates , United Kingdom , Venezuela , Vietnam and Yemen.", "openfda": { "k_number": [ "K770520", "K780499", "K905214", "K852537", "K791663", "K811213", "K812246", "K905261", "K873858", "K760078", "K962355", "K971270", "K781284", "K802470", "K970016", "K821725", "K832469", "K936229", "K791232", "K934517", "K810211", "K802883", "K801843", "K801123", "K873737", "K922771", "K963127", "K883479", "K894200", "K840222", "K964310", "K971779", "K770738", "K831434", "K870968", "K853703", "K810798", "K832353", "K932747", "K830808", "K833853", "K983439", "K931600", "K760057", "K962760", "K781481", "K770677", "K991692", "K952557", "K903432", "K790908", "K981824", "K923015", "K963827", "K772108", "K895840", "K963833", "K897001", "K896900", "K840050", "K905410", "K962508", "K983434", "K934764", "K772122", "K800436", "K925436", "K960550", "K915792", "K991311", "K791375", "K903433", "K894993", "K923571", "K770648", "K001607", "K965058", "K905656", "K812611", "K771142", "K960913", "K831064", "K834049", "K780492", "K944808", "K881373", "K991252", "K780292", "K842949", "K910737", "K812666", "K800374", "K770201", "K820251", "K780018", "K926345", "K914467", "K973966", "K810351", "K864452", "K791588", "K961236", "K904098", "K883810", "K840959", "K832164", "K953160", "K880388", "K894238", "K904820", "K790581", "K893620", "K885195", "K974634", "K842590", "K974027", "K771623", "K803261", "K955435", "K932608", "K860252", "K792539", "K940833", "K820763", "K780787", "K801125", "K770739", "K880087", "K960412", "K772177", "K803180", "K873945", "K851676", "K791317", "K834348", "K963687", "K771220", "K923258", "K830980", "K872191", "K761305", "K881214", "K770918", "K790960" ], "registration_number": [ "3022178699", "3004434309", "3002806944", "2250051", "2122870", "3011989923", "2432235", "1036362", "9612316", "2517506", "3007113174", "3033967997", "3009092698", "3017379203", "8031673", "8020888", "8023018", "2029372", "2245285", "1219913", "8010132", "3007349751", "9610126", "2032682", "3002809144", "3005094123", "3002800697", "3006198300", "3009984016", "3004192065", "3007111389", "2020726", "9610240", "1832216", "3005984081", "1222302", "3007118747", "1319681", "3017894300", "3012963943", "1827821", "2032839", "3002642396", "3000308930", "3005333358", "3017019647", "9680746", "3003741796", "3009335633", "3005529799" ], "fei_number": [ "3022178699", "3002807272", "3004434309", "3002806944", "3002808328", "2250051", "2122870", "3004185580", "3011989923", "2432235", "1036362", "2517506", "3007113174", "3033967997", "3009092698", "3017379203", "2967", "1000306617", "1000136573", "2245285", "1219913", "3007349751", "3002808212", "3002809144", "3005094123", "3002800697", "3007019572", "3006198300", "3009984016", "1000121039", "3004192065", "3007111389", "2020726", "3005984081", "1832216", "3002806559", "3007118747", "3017894300", "3012963943", "1827821", "3002642396", "3000308930", "3003952975", "3005333358", "1000206808", "3002806808", "3017019647", "3003741796", "3009335633", "3005529799" ], "device_name": "Radioimmunoassay, Total Triiodothyronine", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1710", "device_class": "2" } } ] }