{ "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": "131170", "product_res_number": "Z-0827-2015", "event_date_initiated": "2014-10-23", "event_date_posted": "2014-12-18", "recall_status": "Terminated", "event_date_terminated": "2015-02-26", "res_event_number": "69622", "product_code": "CFR", "k_numbers": [ "K011900" ], "product_description": "Glucose Hexokinase (Liquid) Reagent\n\nFor the in vitro quantitative determination of Glucose in serum.", "code_info": "Lot: N0702011K, Exp. 10/2014; N0702012, Exp. 10/2014; N0702013K, Exp. 10/2014; P010201K, Exp. 04/2015; P010202K, Exp. 04/2015; P010203K, Exp. 04/2015; P010204K, Exp. 04/2015; P010205K, Exp. 04/2015; P010206K, Exp. 04/2015; P0402015K, Exp. 07/2015; P0402016K, Exp. 07/2015; P050207K, Exp. 08/2015; P050208K, Exp. 08/2015; P050209K, Exp. 08/2015; P0502010K, Exp. 08/2015; P0502011K, Exp. 08/2015; P0502012K, Exp. 08/2015; P0502013K, Exp. 08/2015; P0502014K, Exp. 08/2015; and P0802017K, Exp. 11/2015.", "firm_fei_number": "3003071743", "recalling_firm": "JAS Diagnostics Inc.", "address_1": "14100 Nw 57th Ct", "city": "Miami Lakes", "state": "FL", "postal_code": "33014-3107", "additional_info_contact": "Lynne S. Broderick, PhD\n305-418-2320", "reason_for_recall": "Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.", "root_cause_description": "Under Investigation by firm", "action": "On October 23, 2014, JAS Diagnostics, Inc. sent out an IMPORTANT PRODUCT RECALL INFORMATION letter asking its consignees to discontinue use of the Glucose Hexokinase lots immediately. Customers are to contact the Service Department at 305-748-2762 or 305-748-2763 for information regarding reimbursement. Also, customers are to complete the attached Certificate of Destruction and return the document to JAS Diagnostics.", "product_quantity": "390", "distribution_pattern": "Worldwide Distribution -- US, including the states of NV, TN, TX, FL, GA, NY, NC, CA, MN, OR and Puerto Rico; and, the countries of France, Jamaica, Haiti, Cayman Islands, Trinidad & Tobago, and Ghana.", "openfda": { "k_number": [ "K801052", "K843541", "K896028", "K761240", "K011900", "K061048", "K980883", "K791760", "K922232", "K990981", "K062239", "K844998", "K052007", "K101854", "K964004", "K884736", "K072018", "K001403", "K821470", "K821868", "K924572", "K760247", "K882334", "K863259", "K942963", "K832872", "K931402", "K841555", "K061879", "K811849", "K092603", "K191899", "K951058", "K103531", "K801051", "K923129", "K781723", "K131189", "K092506", "K922811", "K792532", "K884021", "K931890", "K761320", "K912251", "K760055", "K912808", "K971467", "K831560", "K000556", "K782136", "K953847", "K953210", "K770844", "K060383", "K090703", "K770262", "K801765", "K971276", "K790786", "K113131", "K853464", "K780072", "K801297", "K031135", "K252357", "K170316", "K780065", "K842510", "K945908", "K812595", "K821461", "K112377", "K041052", "K023739", "K971754", "K011963", "K770311", "K012668", "K873936", "K801456", "K072140", "K894394", "K153644", "K980026", "K080123", "K894483", "K984574", "K060256", "K860724", "K901122", "K020852", "K926361", "K780858", "K821475", "K081276", "K802810", "K874846", "K960084", "K123018", "K914794", "K855153", "K770886", "K062118", "K961282", "K871976", "K880236", "K923018", "K853826", "K024281", "K761345", "K812303", "K924601", "K103788", "K891923", "K923040", "K962435", "K944406", "K151487", "K120681", "K000102", "K843150", "K052163", "K861311", "K042767", "K860625", "K970664", "K897160", "K771384", "K080468", "K952437", "K873835", "K771311", "K253490", "K780515", "K905144", "K002199", "K871456", "K981185", "K770229", "K220134", "K905227", "K771464", "K120369", "K934900" ], "device_name": "Hexokinase, Glucose", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1345", "device_class": "2", "registration_number": [ "1181121", "2032900", "9614698", "3016244760", "3009156722", "3011989923", "3007662974", "2432235", "3005146313", "2050012", "3016438761", "1220972", "2050010", "1063851", "3004378326", "3000148879", "3010324880", "3007603826", "3013660430", "3020917535", "9610126", "1415939", "2221819", "3002809144", "3005094123", "3010825766", "3006198300", "3004192065", "1832216", "3004493545", "9610529", "9614673", "2030861", "2247288", "3003795116", "3004438098", "1827821", "1616487", "9610942", "8020316", "3005333358", "3006716639", "9680746", "2085064", "2517506", "1000256526" ], "fei_number": [ "1181121", "3016244760", "3009156722", "3011989923", "3007662974", "1000442352", "2432235", "3005146313", "2050012", "3002806560", "3016438761", "1220972", "3000215862", "2050010", "1000122044", "3004378326", "3000148879", "3003559576", "3010324880", "3007603826", "3007262384", "3013660430", "1000135102", "3002806809", "3004445302", "3020917535", "1415939", "2221819", "3002809144", "3005094123", "3010825766", "3006198300", "3004192065", "1832216", "3004493545", "3002806559", "3003795116", "3004438098", "1827821", "1616487", "3005333358", "1000206808", "3006716639", "3002808382", "2517506", "1000256526" ] } } ] }