{ "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": "114995", "product_res_number": "Z-0698-2013", "event_date_initiated": "2012-12-12", "event_date_posted": "2013-01-23", "recall_status": "Terminated", "event_date_terminated": "2016-12-23", "res_event_number": "63912", "product_code": "MRG", "k_numbers": [ "K110619" ], "product_description": "Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.", "code_info": "ARCHITECT 25-OH Vitamin D Reagent Kit list 3L52, lot numbers 02412C000, exp. 12/26/2012; 02512C000, exp. 12/26/2012; 02012G000, exp. 7/16/2013; 01612G000, exp. 7/17/13; 00912G000, exp. 7/10/13; 02512I000, exp. 10/8/2013; 02612I000, exp. 10/8/2013; 03512I000, exp. 10/10/2013; 03712I000, exp. 10/10/13; when used with ARCHITECT Reaction Vessel (RV) list 7C15-01, box lot numbers (bag lot numbers): 19320P100 (6F9891501); 19344P100 (4N5891091); 19404P100 (1J1948151);  19322P100 (LM3891731); 19373P100 (6F9891521); 19407P100 (4N5948361); 19324P100 (NK8891921); 19374P100 (JG7891631); 19408P100 (5P4948471); 19340P100 (1J1890911); 19375P100 (LM3891741); 19497P100 (2L2948281); 19341P100 (2L2891001); 19379P100 (NK8891931); 20026P100 (LM3947841)", "firm_fei_number": "1415939", "recalling_firm": "Abbott Laboratories", "address_1": "100 Abbott Park Rd", "city": "Abbott Park", "state": "IL", "postal_code": "60064-3502", "additional_info_contact": "Customer Service\n877-422-2788", "reason_for_recall": "The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.", "root_cause_description": "Mixed-up of materials/components", "action": "Abbott Laboratories sent a \"Product Correction Immediate Action Required\" letter dated December 12, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. \n\nThe customers were instructed to immediately discontinue use and destroy any remaining inventory of the reaction vessel lots listed; to clear the ARCHITECT RV hopper of impacted RV lots following the instructions provided, prior to continued use of the ARCHITECT 25-OH Vitamin D assay; to review the patient results obtained with the affected lots with the treating physician or heath care provider to ensure they are aware of the potential analytical issue and can determine whether re-evaluation of the patient is necessary; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; and to retain a copy of the letter for their records and to complete and return the Customer Reply Form via fax to: 1-800-777-0051 \n\nFor further questions please call your local Customer Service representative at 877-422-2688.", "product_quantity": "28,600 total", "distribution_pattern": "Worldwide Distribution -- USA (nationwide) \nand the countries of Austria, Barbados, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Latvia, Libya, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey and United Kingdom.", "openfda": { "k_number": [ "K110619", "K142351", "K071480", "K123253", "K032844", "K172992", "K051110", "K221817", "K232587", "K112725", "K210901", "K091849", "K122420", "K162298", "K014030", "K953567", "K123364", "K200509", "K042519", "K133410", "K180577", "K123983", "K191499", "K102432", "K142373", "K021163", "K072536", "K123660", "K121608", "K110586", "K162840", "K113546", "K161831", "K150270", "K141463", "K162754", "K991998", "K141114", "K142362", "K153361", "K223503", "K140554", "K132492", "K153375", "K123131", "K133156" ], "registration_number": [ "2432235", "9612316", "8031673", "2182595", "3007349751", "3022178699", "2245285", "8023018", "2020726", "3005360469", "3005529799", "2032900", "3002642396", "3002809144", "3007111389", "3009518015", "2915274", "1219913", "3002637618", "3011989923", "2029372", "1063851", "9610126", "2122870", "8021924", "2250051", "3009335633", "3010610113", "9680746", "3009092698", "3007118747", "2517506", "1222302", "3007361513", "3021841051", "3010324880", "2032682", "3000308930", "3005094123", "3005174594", "1319681", "3005333358", "3002800697", "2244821", "2032839", "3012963943", "9615777", "2032087", "3003268355", "3032705", "3014862385" ], "fei_number": [ "3002808328", "2432235", "3005670738", "3007349751", "3002806559", "2182595", "3022178699", "2245285", "1000206808", "2020726", "3007034602", "3005529799", "3002807272", "3002642396", "3002809144", "1000306617", "3007111389", "3003355251", "3009518015", "2915274", "1219913", "3002637618", "3011989923", "3002701146", "3002485711", "3004185580", "1000121039", "2122870", "2250051", "3009335633", "3010610113", "3003952975", "3009092698", "1000136573", "3007118747", "3004445302", "2517506", "3007361513", "3021841051", "3010324880", "3000308930", "3005094123", "3005174594", "2967", "3005333358", "3002800697", "2244821", "3012963943", "3003268355", "1000442352", "3014862385" ], "device_name": "System, Test, Vitamin D", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1825", "device_class": "2" } } ] }