{ "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": "114159", "product_res_number": "Z-0289-2013", "event_date_initiated": "2012-09-14", "event_date_posted": "2012-11-14", "recall_status": "Terminated", "event_date_terminated": "2012-11-29", "res_event_number": "63536", "product_code": "CGX", "k_numbers": [ "K072115" ], "product_description": "ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. \nThe ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives.\n\nABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.", "code_info": "Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.", "firm_fei_number": "3002698356", "recalling_firm": "Horiba Instruments, Inc dba Horiba Medical", "address_1": "34 Bunsen", "city": "Irvine", "state": "CA", "postal_code": "92618-4210", "additional_info_contact": "949-453-0500 Ext. 208", "reason_for_recall": "This recall was initiated because some customers were experiencing an alarm during Creatinine calibration \"REAG RANGE HIGH\". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay.", "root_cause_description": "Nonconforming Material/Component", "action": "HORIBA Medical sent customer communication letters dated October 24, 2011, to all affected customers via Fax with the exception of two communications that were emailed. The response or confirmation of receipt was conducted via telephone and also documented on attached Notification List. Customers were given a list of procedures to follow and asked to complete and fax the Acknowledgement of Receipt Form to +33 (0)4 67 14 15 17.\nFor questions regarding this recall call 949-453-0500, ext 208.", "product_quantity": "8,503 units", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K771335", "K023407", "K771365", "K780514", "K855193", "K132638", "K943005", "K040976", "K802156", "K822118", "K880843", "K983937", "K873531", "K861655", "K860418", "K812834", "K761279", "K221813", "K843179", "K813043", "K890671", "K133728", "K001769", "K902172", "K842159", "K863738", "K923039", "K782094", "K873365", "K792397", "K791994", "K901298", "K800583", "K863261", "K884734", "K771773", "K893582", "K895847", "K881856", "K071277", "K770454", "K941837", "K902561", "K934587", "K854178", "K843105", "K981799", "K844024", "K905658", "K933697", "K812109", "K844332", "K770819", "K913707", "K161494", "K033058", "K071283", "K821199", "K873131", "K841377", "K803087", "K811659", "K870366", "K951595", "K821881", "K772107", "K924692", "K000055", "K881400", "K963534", "K903296", "K761280", "K771443", "K791689", "K242685", "K831628", "K772157", "K771834", "K823573", "K926511", "K874088", "K781884", "K071280", "K830447", "K972743", "K970087", "K901229", "K771916", "K931939", "K900666", "K991109", "K934071", "K800219", "K915077", "K770643", "K832439", "K923526", "K840872", "K872310", "K800685", "K002156", "K851993", "K852565", "K831627", "K072115", "K791688", "K981240", "K895022", "K932160", "K945655", "K792404", "K974909", "K843377", "K925668", "K955938", "K973993", "K811664", "K050652", "K792402", "K210452", "K252206", "K770242", "K971908", "K850932", "K896686", "K873310", "K954266", "K771856", "K863079", "K873725", "K003247", "K934361", "K813560", "K060935", "K923203", "K061193", "K851849", "K083809", "K854846", "K251058", "K861819", "K880629", "K820075", "K910147", "K924599", "K811406", "K830556", "K781396", "K843916", "K905619", "K950142", "K790044", "K943924", "K853888", "K123586", "K823806", "K823572", "K830537", "K110530" ], "device_name": "Alkaline Picrate, Colorimetry, Creatinine", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1225", "device_class": "2", "registration_number": [ "3002637618", "1220972", "3003795116", "1832216", "3003593973", "1827821", "3004875840", "9610633", "9610529", "1818910", "3002809144", "3016438761", "2432235", "3005094123", "3021841051", "3010825766", "2050012", "3023162659", "9616671", "1219029", "3005146313", "9610126", "2050010", "2247288", "1181121", "3011989923", "3003030793", "3005333358", "8020316", "1063851", "9680746", "2939693", "3004493545", "1616487", "2085064", "3006716639", "3000148879", "2517506", "3004192065", "3006198300", "2030861" ], "fei_number": [ "3002637618", "1220972", "3003795116", "1832216", "3003593973", "1827821", "3004875840", "1000122044", "3002854251", "1818910", "1000442352", "3002809144", "3002806809", "3016438761", "2432235", "3005094123", "3021841051", "3010825766", "2050012", "3023162659", "1219029", "3005146313", "2050010", "1000206808", "1181121", "3011989923", "3003030793", "3005333358", "3002806560", "3000215862", "2939693", "3004493545", "3002806693", "1616487", "3006716639", "3000148879", "2517506", "3004192065", "3006198300", "3002806559", "1000135102" ] } } ] }