{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216613", "product_res_number": "Z-0725-2026", "event_date_initiated": "2025-09-17", "event_date_posted": "2025-11-28", "recall_status": "Open, Classified", "res_event_number": "97802", "product_code": "KHE", "k_numbers": [ "K170548" ], "product_description": "InSure ONE Fecal Immunochemical Test. Labeled as follows:\n\n1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010.\n\n2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025.\n\n3. InSure ONE POL Combo Pack. Model Number: 90030.\n\nInSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.", "code_info": "1. Model Number: 90010; GTIN:10850093003313; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. \n\n2. Model Number: 90025; GTIN: 20850093003310; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. \n\n3. Model Number: 90030; GTIN: 00850093003279; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.", "firm_fei_number": "3003224146", "recalling_firm": "Enterix, Inc.", "address_1": "236 Fernwood Ave", "city": "Edison", "state": "NJ", "postal_code": "08837-3839", "additional_info_contact": "Erica Franco\n732-429-1899", "reason_for_recall": "InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.", "root_cause_description": "Under Investigation by firm", "action": "Consignees were initially sent an email as notification of the recall on about 09/17/2025, which was followed by a formal recall notification letter on about 09/23/2025. Consignees were instructed to immediately examine inventory and quarantine any affected units, notify customers if affected further distributed, and for those patients that have already been tested using an InSure ONE test kit that has been identified as part of the scope of this recall be retested. Once an inventory count has been received by Enterix, they will provide RMA and courier information so the recalled product can be returned for sorting and destruction.", "product_quantity": "201,426 test kits", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.", "openfda": { "k_number": [ "K102664", "K030216", "K003359", "K936056", "K883432", "K896474", "K070660", "K874180", "K921798", "K871143", "K873409", "K143325", "K902360", "K905798", "K843352", "K884206", "K880499", "K073431", "K811815", "K022755", "K063673", "K840903", "K113506", "K901064", "K060930", "K832311", "K173212", "K002457", "K992759", "K812728", "K832864", "K171484", "K854619", "K163554", "K060953", "K100817", "K800433", "K840527", "K810488", "K843532", "K060463", "K100031", "K820072", "K780564", "K813204", "K834297", "K063693", "K854358", "K812428", "K080812", "K021423", "K855237", "K051806", "K874482", "K972763", "K761232", "K861731", "K031356", "K913622", "K911075", "K811752", "K912979", "K980671", "K792655", "K834456", "K061065", "K981661", "K840904", "K071242", "K033548", "K830919", "K882799", "K821884", "K770153", "K041202", "K833369", "K842137", "K850431", "K002756", "K830223", "K110309", "K041297", "K961062", "K780214", "K984269", "K121397", "K881907", "K170548", "K052598", "K905782", "K853141", "K162333", "K843601", "K860028", "K862849", "K822731", "K002930" ], "registration_number": [ "3008517993", "9710094", "3030708766", "3026478115", "1226769", "3005610352", "3002637618", "1518939", "1649661", "2435505", "3005345870", "2250030", "3015751263", "3025041446", "3021090658", "3009238284", "2024674", "1123776", "2030633", "2029372", "3023322455", "3007606081", "3033507883", "3003917514", "3026478116", "2087033", "1061932", "9611917", "3005174594", "1000369487", "3033751096", "3012516456", "2410251", "3004569406", "3004635103", "1832216", "3043196750", "2050010", "3005984081", "2032839", "3007301207", "1017835", "2030538", "2025099", "1616487", "3005360469", "3022178699", "3021186226", "3006621318", "2246703", "2060833", "3002792284", "3011945100", "3016609999", "3042471840", "2014676", "3005311019", "3011287770", "2244821", "3024753119", "1417592", "3017231634", "9610126", "1618982" ], "fei_number": [ "3008517993", "3005670738", "3030708766", "3026478115", "1518939", "3002637618", "2250030", "3005345870", "3015751263", "3025041446", "3021090658", "3009238284", "2024674", "3004185580", "3023322455", "3007606081", "3033507883", "3003917514", "3026478116", "3002806884", "3003224146", "3009431614", "3007981058", "3005174594", "1000369487", "3033751096", "3012516456", "2410251", "3004569406", "3003102569", "3004635103", "1000520007", "1832216", "3043196750", "3000210620", "2050010", "3002806559", "3005984081", "3007301207", "1017835", "3001452245", "1000119795", "3003347234", "3001451797", "1616487", "3022178699", "3021186226", "3006621318", "2246703", "3002792284", "3011945100", "3016609999", "3042471840", "1000219815", "2014676", "3005311019", "3000203293", "3011287770", "2244821", "3024753119", "1417592", "3017231634", "1000306617", "1618982" ], "device_name": "Reagent, Occult Blood", "medical_specialty_description": "Hematology", "regulation_number": "864.6550", "device_class": "2" } } ] }