{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "141190", "product_res_number": "Z-0312-2016", "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": "Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5;\nImmutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP;\nImmutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP;\nImmutest 5 panel, Item No. IMCA-5AB-W;\nImmutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W;\nImmutest 7 panel, Item No. IMCA-7P;\nImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P\n\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": "144380 144564 150505 150908 151538 142098 144103 150313 150909 141645 144563 150483 151337 142076 142966 144263 151540", "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": "1172 units", "distribution_pattern": "Worldwide Distribution - US (nationwide) and Internationally to Australia.", "openfda": { "k_number": [ "K190968", "K930529", "K221765", "K910376", "K870994", "K962672", "K012300", "K914815", "K942795", "K851568", "K023048", "K012131", "K002342", "K934869", "K123080", "K991443", "K043167", "K973326", "K092274", "K980776", "K874265", "K163590", "K961325", "K151642", "K810463", "K862250", "K173963", "K062285", "K891697", "K944076", "K993985", "K890001", "K060354", "K926067", "K915501", "K151771", "K982831", "K873538", "K032365", "K043556", "K842815", "K983702", "K000458", "K051307", "K883730", "K896744", "K981687", "K890691", "K910590", "K896780", "K951288", "K163704", "K960708", "K050179", "K991079", "K840236", "K954626", "K992720", "K790736", "K983174", "K974181", "K950427", "K153597", "K951286", "K940159", "K951710", "K150356", "K953105", "K043327", "K013882", "K880014", "K011306", "K000449", "K973269", "K003879", "K863877", "K013143", "K003881", "K802616", "K874376", "K842387", "K874489", "K945829", "K243498", "K962734", "K883459", "K111322", "K914509", "K931536", "K833578" ], "registration_number": [ "", "3003795116", "3012073813", "1827821", "2030633", "3008517993", "2027969", "2432235", "3009473156", "3023322455", "3004635103", "3008852306", "9610126", "3000308930", "3023296261", "3003917514", "3008987086", "3009414546", "3009585529", "3009212837", "3031697086", "3017904598", "3010934853", "3034694973", "3006198300", "3024463179", "2030861", "3030648160", "3043127647", "2031229", "1319808", "3010939897", "2025099", "8043323", "3013679502", "3013982035", "2050012", "3013684380", "2087033", "1649661", "2250051", "2246703", "3011522054", "3004175381", "1063851", "3021186226", "2020952", "3006305917", "3010800486", "3016609999", "3027519599", "3005984081", "1220972", "2029372", "3012725363", "3014607865", "2132111", "3012963943", "3002642396", "1050155", "3005333358", "9680746", "3005641941", "3004493545", "3005345870", "3010852191", "1832216", "1910144", "9610529", "3009238284", "3008416529", "3007126977", "3030413233", "2060833", "3005360469", "3007838093", "3010825766", "3006048451", "2050010", "3011559327", "3011989923", "3005174594", "1319681", "2915274", "3010220539", "2090110", "3007606081", "3003610499", "3036649420", "2517506", "3004987297" ], "fei_number": [ "", "3003795116", "3012073813", "1827821", "3008517993", "2432235", "3009473156", "3023322455", "3004635103", "3008852306", "3000308930", "3023296261", "3003917514", "3008987086", "3009414546", "3009585529", "3009212837", "3031697086", "3017904598", "3010934853", "3034694973", "3006198300", "3024463179", "3030648160", "3001451797", "3043127647", "1000305841", "3010939897", "3013679502", "3013982035", "2050012", "3013684380", "3006078362", "1000206808", "2250051", "2246703", "3011522054", "3004175381", "3021186226", "1000140026", "2020952", "3006305917", "3010800486", "3016609999", "3027519599", "3005984081", "1000306617", "1220972", "3003102569", "3012725363", "1000442352", "3014607865", "3001452245", "3012963943", "3002642396", "1050155", "3000719950", "3005333358", "1000125596", "3002806560", "3000215862", "3005641941", "3005670738", "3004493545", "3005345870", "1000136573", "3010852191", "3002806559", "1832216", "1910144", "3009238284", "3008416529", "3007126977", "3030413233", "3007838093", "3010825766", "3007981058", "3006048451", "2050010", "3011559327", "3011989923", "3005174594", "2915274", "3010220539", "3007606081", "3003610499", "3002346973", "3036649420", "2517506", "3000210620", "3004987297" ], "device_name": "Enzyme Immunoassay, Benzodiazepine", "medical_specialty_description": "Clinical Toxicology", "regulation_number": "862.3170", "device_class": "2" } } ] }