{ "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": "73812", "product_res_number": "Z-0480-2009", "event_date_initiated": "2008-10-03", "event_date_posted": "2008-12-29", "recall_status": "Terminated", "event_date_terminated": "2009-03-26", "res_event_number": "49560", "product_code": "KHE", "k_numbers": [ "K060930" ], "product_description": "INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits.\n\nProduct Number 30025 - InSure(R) Quik FIT)TM) Developer Kit (1 Box) . Each box contains: 25 InSure(R) Quik FIT(TM) Test Strips (1 per foil pack), 1 InSure(R) Quik FIT(TM) Conjugate Solution, I InSure(R) Quik FIT(TM) Run Buffer, and 1 InSure(R) Quik FIT(TM) Product Instructions.\n\nProduct 50025 - InSure(R) Quik FIT(TM) contains 25 Patient Kits & 1 Developer Kit.", "code_info": "Lot number B1478, Exp. Date 11/30/2008", "firm_fei_number": "3003224146", "recalling_firm": "Enterix, Inc.", "address_1": "236 Fernwood Ave", "city": "Edison", "state": "NJ", "postal_code": "08837-3839", "additional_info_contact": "Edwin Diaz\n732-429-1899", "reason_for_recall": "False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531--3681.", "root_cause_description": "Other", "action": "Medical Device Recall Letters were sent on October 3, 2008 to all customers by certified mail. The letters were entitled \"URGENT *** MEDICAL DEVICE RECALL (U.S. ONLY). Questions are to be directed to Enterix at 1-800-531-3681,", "product_quantity": "45 kits (includes 25 patient collection kits and 1 developer kit)", "distribution_pattern": "Product was distributed to medical facilities and laboratories throughout the US.", "openfda": { "k_number": [ "K980671", "K880499", "K843601", "K853141", "K843352", "K071242", "K170548", "K811752", "K100031", "K961062", "K060953", "K832311", "K022755", "K031356", "K874482", "K921798", "K871143", "K850431", "K861731", "K813204", "K981661", "K912979", "K003359", "K902360", "K030216", "K002756", "K936056", "K100817", "K080812", "K821884", "K070660", "K840904", "K812428", "K052598", "K063693", "K905782", "K780564", "K905798", "K060463", "K860028", "K830223", "K911075", "K770153", "K881907", "K761232", "K800433", "K896474", "K171484", "K121397", "K842137", "K780214", "K984269", "K113506", "K883432", "K882799", "K830919", "K162333", "K855237", "K992759", "K862849", "K810488", "K051806", "K901064", "K041297", "K021423", "K063673", "K834297", "K820072", "K110309", "K913622", "K163554", "K832864", "K874180", "K792655", "K041202", "K854619", "K834456", "K840903", "K884206", "K854358", "K102664", "K873409", "K840527", "K843532", "K002930", "K173212", "K143325", "K822731", "K972763", "K073431", "K033548", "K812728", "K833369", "K002457", "K811815", "K060930", "K061065" ], "registration_number": [ "3002637618", "3004635103", "3022178699", "1061932", "2244821", "3011945100", "3005610352", "1417592", "2024674", "3002792284", "1518939", "9611917", "2050010", "2060833", "2246703", "1000369487", "3015751263", "1226769", "3021090658", "2029372", "2030633", "3003917514", "3023322455", "9610126", "3021186226", "3005345870", "3024753119", "2410251", "3005174594", "3004569406", "1123776", "3007606081", "2014676", "3005984081", "3005360469", "3011287770", "1832216", "3042471840", "3007301207", "1649661", "2025099", "3030708766", "3009238284", "1618982", "1017835", "3006621318", "3017231634", "3043196750", "2032839", "1616487", "2030538", "2087033", "2435505", "2250030", "3033507883", "3026478116", "3016609999", "3012516456", "3025041446", "3008517993", "3005311019", "9710094", "3026478115", "3033751096" ], "fei_number": [ "3002637618", "3004635103", "3022178699", "2244821", "3011945100", "1000219815", "3004185580", "1417592", "2024674", "3003347234", "3000210620", "3002792284", "1518939", "2050010", "2246703", "1000369487", "3015751263", "3003102569", "1000306617", "3009431614", "3021090658", "3000203293", "3003917514", "3023322455", "3001451797", "3021186226", "3005345870", "3024753119", "2410251", "3005174594", "3004569406", "3007606081", "2014676", "3005984081", "3011287770", "1832216", "3042471840", "3007301207", "3002806559", "1000520007", "3030708766", "3009238284", "1618982", "3007981058", "3003224146", "3006621318", "3002806884", "3017231634", "1017835", "3043196750", "1616487", "2250030", "3005670738", "3033507883", "1000119795", "3026478116", "3016609999", "3012516456", "3025041446", "3008517993", "3005311019", "3001452245", "3026478115", "3033751096" ], "device_name": "Reagent, Occult Blood", "medical_specialty_description": "Hematology", "regulation_number": "864.6550", "device_class": "2" } } ] }