{ "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": "41986", "product_res_number": "Z-0132-06", "event_date_initiated": "2005-09-07", "event_date_posted": "2005-11-15", "recall_status": "Terminated", "event_date_terminated": "2006-03-30", "res_event_number": "33515", "product_code": "GJS", "k_numbers": [ "K020679", "K021923" ], "product_description": "HemoSense brand INRatio Prothombin Time Monitoring System,\nSoftware Version 1.25.21;\n\nProduct is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134", "code_info": "Serial Numbers: \t 044609678,\t051613670,\t051613713,\t052613997,\t052614025, 044810630,\t051613674,\t051613714,\t052613998,\t052614026, 044810759,\t051613675,\t051613721,\t052613999,\t052614027, 045110807,\t051613676,\t051613722,\t052614000,\t052614028, 045110825,\t051613679,\t051613723,\t052614002,\t052614029, 051613114,\t051613681,\t051613730,\t052614003,\t052614030, 051613119,\t051613682,\t051613733,\t052614004,\t052614031, 051613121,\t051613683,\t051613742,\t052614006,\t052614032, 051613125,\t051613685,\t051613745,\t052614007,\t052614033, 051613127,\t051613686,\t051613746,\t052614008,\t052614035, 051613154,\t051613687,\t051613747,\t052614010,\t052614040, 051613156,\t051613689,\t051613748,\t052614011,\t052614042, 051613164,\t051613691,\t052613972,\t052614012,\t052614045, 051613174,\t051613693,\t052613975,\t052614013,\t052614049, 051613241,\t051613695,\t052613978,\t052614014,\t052614050, 051613247,\t051613696,\t052613979,\t052614015,\t052614051, 051613256,\t051613697,\t052613981,\t052614016,\t052614060, 051613261,\t051613701,\t052613984,\t052614017,\t052614063, 051613655,\t051613702,\t052613986,\t052614018,\t052614065, 051613656,\t051613704,\t052613991,\t052614019,\t052614072, 051613660,\t051613705,\t052613992,\t052614020,\t052614078, 051613661,\t051613707,\t052613993,\t052614021,\t052614079 051613662,\t051613710,\t052613994,\t052614022,\t052614085, 051613663,\t051613711,\t052613995,\t052614023,\t 051613665,\t051613712,\t052613996,\t052614024", "firm_fei_number": "3003038758", "recalling_firm": "HemoSense Inc", "address_1": "651 River Oaks Pkwy", "city": "San Jose", "state": "CA", "postal_code": "95134-1907", "reason_for_recall": "A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.", "root_cause_description": "Other", "action": "On 9/7/05, the firm issued letters via Federal Express and telephone follow-up to all its consignees, informing them of the affected product and providing instructions on the recall.", "product_quantity": "123 units", "distribution_pattern": "Product was released for distribution to 20 consignees in US.\n\nThe recall was appropriately extended to the consumer/user level; i.e., the users who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.", "openfda": { "k_number": [ "K092987", "K231711", "K972796", "K885107", "K902468", "K092940", "K931117", "K810350", "K893378", "K901325", "K201185", "K951820", "K780203", "K920767", "K791023", "K955843", "K913250", "K994006", "K843535", "K052124", "K243543", "K072920", "K942884", "K935748", "K060931", "K021923", "K060978", "K832427", "K170960", "K220282", "K904454", "K930212", "K072727", "K921326", "K882214", "K903019", "K840802", "K070005", "K211485", "K180684", "K905857", "K093460", "K043184", "K884855", "K896625", "K925492", "K911995", "K122584", "K213426", "K864283", "K012768", "K864272", "K062925", "K992492", "K961938", "K811784", "K952608", "K251564", "K945078", "K994100", "K882456", "K935702", "K874592", "K872537", "K962571", "K991286", "K230802", "K183255", "K021190", "K872844", "K864274", "K891169", "K791022", "K913249", "K071041", "K940310", "K922040", "K991065", "K915746", "K954625", "K891370", "K003870", "K922565", "K940082", "K180693", "K883441", "K974343", "K852484", "K020840", "K020831", "K931118", "K020355", "K212779", "K180780", "K022922", "K981479", "K974566", "K010599", "K860721", "K030845", "K933252", "K904325", "K093243", "K880566", "K110212", "K001699", "K851125", "K905807", "K870596", "K020679", "K864392", "K961835", "K902096", "K132722", "K972866", "K013155", "K875062", "K864273", "K792031", "K151964", "K040296", "K940432", "K830331", "K925604", "K892050", "K253188", "K912102" ], "device_name": "Test, Time, Prothrombin", "medical_specialty_description": "Hematology", "regulation_number": "864.7750", "device_class": "2", "registration_number": [ "3010285483", "3007507465", "3013660430", "3011689956", "9610806", "1219029", "3013188547", "3005643513", "1832816", "3002721930", "9610126", "2245451", "1835316", "3005146313", "1217183", "3013298431", "9710666", "3030186688", "3037000637", "3025915415", "3012302888", "3015499222", "2245578", "3033967997", "2431530", "2432235", "3008386529", "1181121", "2085064", "3006198300", "3003691680", "1618982" ], "fei_number": [ "1000135102", "3010285483", "3007507465", "3013660430", "3011689956", "1219029", "2250033", "3003565434", "3013188547", "3005643513", "1832816", "2245451", "3005146313", "1217183", "3013298431", "3002806559", "3030186688", "3037000637", "3025915415", "3012302888", "3001644026", "3015499222", "2245578", "3033967997", "2431530", "2432235", "3008386529", "1181121", "3003691680", "3006198300", "3000210416", "1618982" ] } } ] }