{ "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": 24 } }, "results": [ { "cfres_id": "82495", "product_res_number": "Z-0006-2010", "event_date_initiated": "2009-04-27", "event_date_posted": "2009-10-06", "recall_status": "Terminated", "event_date_terminated": "2012-04-02", "res_event_number": "52202", "product_code": "DKZ", "k_numbers": [ "K061718" ], "product_description": "Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. \n\nSubsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG", "code_info": "Lot Numbers: DOA8080780, DOA8080781, DOA8080782, DOA8080783 and DOA8080784.", "firm_fei_number": "1000125596", "recalling_firm": "Biosite Inc", "address_1": "9975 Summers Ridge Rd", "city": "San Diego", "state": "CA", "postal_code": "92121", "additional_info_contact": "877-441-7440", "reason_for_recall": "The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.", "root_cause_description": "Process control", "action": "Biosite, Inc. issued a \"Notice of Correction\" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used.\n\nFor further information, contact Biosite, Inc. using the following information:\n\nBiosite Incorporated, an Inverness Medical Company\n9975 Summers Ridge Road\nSan Diego, CA 92121\nPhone: 1-877-441-7440, option 2\nFax: 1-858-695-7100\nEmail: productadvisory@invmed.com", "product_quantity": "113,575 cups distributed in total", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K001225", "K182738", "K033094", "K012745", "K874273", "K994237", "K760936", "K113046", "K011499", "K970395", "K053337", "K994395", "K002447", "K141532", "K990681", "K233019", "K121339", "K152269", "K905700", "K152590", "K992033", "K023104", "K983699", "K842674", "K900995", "K020313", "K032575", "K181945", "K080057", "K023712", "K061617", "K981504", "K121065", "K910658", "K033743", "K053032", "K062077", "K041743", "K833579", "K130811", "K131811", "K874836", "K871696", "K020395", "K182719", "K121987", "K903993", "K930690", "K053175", "K992918", "K874486", "K123863", "K131653", "K071489", "K052882", "K950135", "K041696", "K021006", "K890886", "K010564", "K091588", "K240670", "K874274", "K033659", "K131069", "K992632", "K130463", "K141748", "K051235", "K001397", "K003865", "K043028", "K050394", "K040350", "K142855", "K920507", "K173303", "K760196", "K053359", "K972032", "K102203", "K110446", "K944604", "K990337", "K933052", "K934891", "K935052", "K962411", "K994399", "K191099", "K051579", "K130082", "K153465", "K142800", "K874080", "K050186", "K981705", "K973726", "K003809", "K031004", "K973784", "K012257", "K934693", "K883707", "K943439", "K981197", "K921554", "K040203", "K924476", "K161251", "K020869", "K941372", "K063024", "K083764", "K093664", "K990399", "K900143", "K951154", "K920018", "K002266", "K980865", "K955934", "K012484", "K904115", "K843458", "K131645", "K935573", "K910756", "K063379", "K041685", "K000400", "K092275", "K010645", "K853879", "K802623", "K061005", "K011609", "K152122", "K142580", "K880013", "K011952", "K051966", "K001421", "K914146", "K132812", "K021114", "K022564", "K935042", "K000460", "K873755", "K051161", "K061718", "K001417", "K122419", "K231137", "K910739", "K953115", "K014247", "K143500", "K000606", "K894404", "K874770", "K884022", "K101745", "K080635", "K010177", "K122904", "K102210", "K971109", "K972891", "K974611", "K012110", "K970724", "K904451", "K932304", "K913738", "K180879", "K903824", "K910738", "K111560", "K990418", "K943993", "K131110", "K093114", "K133968", "K894465", "K873622", "K012396", "K902979", "K122809", "K033902", "K122961", "K971218", "K984525", "K031759", "K990325", "K033566", "K200363", "K910278", "K970265", "K004034", "K011673", "K040092", "K955935", "K994380", "K052115", "K882589", "K973075", "K921998", "K945610", "K041822", "K895210", "K931498", "K942836", "K912758", "K152908", "K050540", "K012159", "K151213", "K983770", "K060810", "K972989", "K890692", "K935352", "K040133" ], "registration_number": [ "", "3008517993", "3004635103", "3004175381", "3011522054", "3043127647", "3003917514", "3036649420", "3009212837", "3005641941", "2020952", "2250051", "3011559327", "3016610313", "2027969", "3013982035", "1063851", "2031229", "2246703", "3009414546", "3007606081", "3000308930", "3030413233", "1832216", "1910144", "2050012", "3004493545", "3003610499", "3006305917", "3023322455", "3004847291", "3007838093", "3013077867", "3009585529", "3009238284", "3008416529", "1649661", "9610126", "3006048451", "2060833", "2030861", "3005984081", "3013679502", "1050155", "3010852191", "3006198300", "2000007960", "3017904598", "3024463179", "3010800486", "1319681", "3013684380", "3034694973", "2915274", "1319808", "3016609999", "3027519599", "1827821", "2517506", "3003795116", "3002642396", "3010220539", "3010825766", "3005174594", "3042271096", "3008987086", "2432235", "2090110", "3023296261", "8043323", "2087033", "3010939897", "3030648160", "3012963943", "3031823359", "3007126977", "3009963993", "3008054239", "2050010", "3005360469", "3021186226", "2029372", "2025099", "3012073813", "3005755244", "3004987297", "3014607865", "1036362", "3005345870", "3031697086", "3012725363", "3005333358", "2030633", "3002806944", "3008852306", "3010934853", "9610529" ], "fei_number": [ "", "3008517993", "3004635103", "3004175381", "3011522054", "3043127647", "3003917514", "3036649420", "3009212837", "3005641941", "2020952", "2250051", "3011559327", "3016610313", "3013982035", "1000306617", "2246703", "3009414546", "3007606081", "1000442352", "3000308930", "3030413233", "1832216", "1910144", "2050012", "3004493545", "3003610499", "3006305917", "3023322455", "3004847291", "3007838093", "3013077867", "3009585529", "3009238284", "3002806560", "3008416529", "3006048451", "3002806559", "3005984081", "3013679502", "1050155", "3010852191", "1000125596", "3006198300", "3000210620", "2000007960", "3017904598", "3024463179", "3005670738", "3010800486", "3006078362", "3013684380", "3002346973", "3034694973", "2915274", "3016609999", "3027519599", "1827821", "2517506", "3003795116", "3002642396", "3010220539", "3010825766", "3005174594", "3042271096", "3008987086", "2432235", "3023296261", "3010939897", "3030648160", "3012963943", "3031823359", "3007126977", "3009963993", "3008054239", "2050010", "3021186226", "3012073813", "3005755244", "3001452245", "3007981058", "3004987297", "3014607865", "1036362", "1000136573", "1000305841", "3000215862", "3005345870", "3031697086", "3000719950", "3012725363", "3005333358", "3002806944", "3003102569", "3008852306", "3001451797", "3010934853" ], "device_name": "Enzyme Immunoassay, Amphetamine", "medical_specialty_description": "Clinical Toxicology", "regulation_number": "862.3100", "device_class": "2" } } ] }