{ "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": "141196", "product_res_number": "Z-0316-2016", "event_date_initiated": "2015-10-20", "event_date_created": "2015-11-18", "recall_status": "Terminated", "event_date_terminated": "2016-11-09", "res_event_number": "72471", "product_code": "JXM", "k_numbers": [ "K052115", "K113046", "K113501" ], "product_description": "The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU),\r\n Item No. TDDA-6MBAU-CUP\r\n\r\nThese Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.", "code_info": "G140422-C G150059-C G150063-C G150132-C", "firm_fei_number": "3003789989", "recalling_firm": "Ameditech Inc", "address_1": "9940 Mesa Rim Rd", "city": "San Diego", "state": "CA", "postal_code": "92121-2910", "additional_info_contact": "858-535-1968", "reason_for_recall": "Ameditech is recalling drug abuse tests because they have shown reduced reactivity.", "root_cause_description": "Nonconforming Material/Component", "action": "Ameditech Inc. sent an Urgent Medical Device Recall Letter to al affected customers on October 20, 2015, to inform them that Ameditech is recalling affected lots of Ameditech's Drugs of Abuse Tests because they have shown reduced reactivity for up to three of the nineteen Benzodiazepine (BZO) compounds. The letter informs customers of the actions to be taken. Customers were instructed to complete and return the customer verification form to (858) 677-0243 or scan and email to amt.fieldaction@alere.com. For questions regarding this recall call 858-535-1968.", "product_quantity": "2,240 units", "distribution_pattern": "Worldwide Distribution - US (nationwide) and Internationally to Australia.", "openfda": { "k_number": [ "K940159", "K123080", "K951288", "K896744", "K950427", "K862250", "K111322", "K190968", "K926067", "K173963", "K910376", "K003879", "K221765", "K163704", "K000458", "K003881", "K914509", "K874376", "K991079", "K043167", "K880014", "K092274", "K151642", "K012131", "K951710", "K043327", "K163590", "K890001", "K833578", "K962672", "K930529", "K062285", "K992720", "K982831", "K962734", "K945829", "K961325", "K802616", "K983174", "K896780", "K243498", "K944076", "K150356", "K790736", "K842815", "K810463", "K023048", "K991443", "K043556", "K931536", "K060354", "K012300", "K983702", "K874265", "K883459", "K013882", "K973326", "K974181", "K051307", "K942795", "K842387", "K151771", "K953105", "K050179", "K011306", "K915501", "K973269", "K954626", "K153597", "K002342", "K951286", "K993985", "K870994", "K032365", "K910590", "K980776", "K840236", "K914815", "K013143", "K890691", "K874489", "K851568", "K891697", "K873538", "K981687", "K000449", "K883730", "K934869", "K960708", "K863877" ], "registration_number": [ "", "3008517993", "3004635103", "3004175381", "3011522054", "3043127647", "9680746", "3003917514", "3036649420", "3009212837", "3005641941", "2020952", "2250051", "3011559327", "2027969", "3013982035", "1063851", "2031229", "2246703", "3009414546", "3007606081", "3000308930", "3030413233", "1832216", "1910144", "2050012", "3004493545", "3003610499", "3006305917", "3023322455", "3007838093", "3009585529", "3009238284", "3008416529", "1649661", "9610126", "3006048451", "2060833", "2030861", "3005984081", "3013679502", "1050155", "3010852191", "3009473156", "3006198300", "1220972", "3017904598", "3024463179", "3010800486", "1319681", "3013684380", "3034694973", "2915274", "1319808", "3016609999", "3027519599", "1827821", "2517506", "3003795116", "3002642396", "3010220539", "3010825766", "3005174594", "2090110", "3008987086", "2432235", "3023296261", "2132111", "8043323", "2087033", "3010939897", "3030648160", "3012963943", "3011989923", "3007126977", "2050010", "3005360469", "3021186226", "2029372", "2025099", "3012073813", "3004987297", "3014607865", "3005345870", "3031697086", "3012725363", "3005333358", "2030633", "3008852306", "3010934853", "9610529" ], "fei_number": [ "", "3008517993", "3004635103", "3004175381", "3011522054", "3043127647", "3003917514", "3036649420", "3009212837", "3005641941", "2020952", "2250051", "3011559327", "3013982035", "1000306617", "2246703", "3009414546", "3007606081", "1000442352", "3000308930", "3030413233", "1832216", "1910144", "2050012", "3004493545", "3003610499", "3006305917", "3023322455", "3007838093", "3009585529", "3009238284", "3002806560", "3008416529", "3006048451", "3002806559", "3005984081", "3013679502", "1050155", "3010852191", "3009473156", "1000125596", "3006198300", "3000210620", "1220972", "3017904598", "3024463179", "3005670738", "3010800486", "3006078362", "3013684380", "3002346973", "3034694973", "2915274", "3016609999", "3027519599", "1827821", "2517506", "3003795116", "3002642396", "3010220539", "3010825766", "3005174594", "3008987086", "2432235", "3023296261", "3010939897", "3030648160", "3012963943", "3011989923", "3007126977", "2050010", "3021186226", "3012073813", "3001452245", "3007981058", "3004987297", "3014607865", "1000305841", "1000136573", "3000215862", "3005345870", "1000140026", "3031697086", "3000719950", "3012725363", "1000206808", "3005333358", "3003102569", "3008852306", "3001451797", "3010934853" ], "device_name": "Enzyme Immunoassay, Benzodiazepine", "medical_specialty_description": "Clinical Toxicology", "regulation_number": "862.3170", "device_class": "2" } } ] }