{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "141895", "product_res_number": "Z-0501-2016", "event_date_initiated": "2015-11-16", "event_date_created": "2015-12-24", "recall_status": "Terminated", "event_date_terminated": "2016-11-09", "res_event_number": "72651", "product_code": "JXM", "k_numbers": [ "K052115", "K113046", "K113501" ], "product_description": "EDI BZO Uncut Sheet - Cup*, Item No. 160170", "code_info": "141260 141294 141909 141925 142074 142243 142428 142614 142712 142911 144555 151925 152003 152223 152498 152723 152897 153311 153559 153818 154184 152103", "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": "Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.", "root_cause_description": "Nonconforming Material/Component", "action": "A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at amt.fieldaction@alere.com.", "product_quantity": "45,584 kits", "distribution_pattern": "Nationwide Distribution.", "openfda": { "k_number": [ "K951286", "K883459", "K983702", "K974181", "K060354", "K190968", "K013882", "K043167", "K890001", "K043327", "K790736", "K111322", "K960708", "K991443", "K163704", "K961325", "K930529", "K842815", "K151771", "K926067", "K874489", "K945829", "K983174", "K991079", "K880014", "K050179", "K003881", "K934869", "K870994", "K896780", "K043556", "K221765", "K873538", "K000458", "K012300", "K012131", "K833578", "K890691", "K842387", "K851568", "K931536", "K810463", "K993985", "K962734", "K914509", "K840236", "K243498", "K944076", "K023048", "K002342", "K051307", "K011306", "K003879", "K896744", "K915501", "K062285", "K940159", "K914815", "K980776", "K173963", "K150356", "K951288", "K092274", "K992720", "K962672", "K153597", "K874265", "K982831", "K883730", "K163590", "K910590", "K981687", "K950427", "K954626", "K942795", "K000449", "K013143", "K951710", "K973269", "K953105", "K862250", "K973326", "K123080", "K863877", "K802616", "K910376", "K032365", "K151642", "K891697", "K874376" ], "registration_number": [ "", "2027969", "3027519599", "2432235", "2246703", "3036649420", "3006198300", "2915274", "3004987297", "2517506", "3000308930", "1319681", "2050010", "2030861", "3009212837", "3011559327", "2020952", "3012073813", "2025099", "3003795116", "3013679502", "3023322455", "3034694973", "1649661", "1319808", "3003610499", "1910144", "3004175381", "3011989923", "3008416529", "3010800486", "3004635103", "1832216", "3008517993", "2087033", "3005333358", "3030648160", "3010852191", "3012963943", "3004493545", "3012725363", "3005641941", "3010825766", "3009414546", "2060833", "3031697086", "3013684380", "3013982035", "3006305917", "2031229", "2132111", "2050012", "2030633", "3024463179", "3002642396", "3008852306", "3007838093", "9610126", "3026478115", "3009238284", "1050155", "3011522054", "2250051", "2090110", "3017904598", "3030413233", "3021186226", "3007126977", "3010220539", "3005174594", "3006048451", "9610529", "3008987086", "3009585529", "8043323", "3023296261", "1220972", "3005360469", "3010939897", "1827821", "2029372", "1063851", "3014607865", "3009473156", "3026478116", "9680746", "3007606081", "3016609999", "3005984081", "3003917514", "3010934853", "3005345870", "3043127647" ], "fei_number": [ "", "2432235", "3027519599", "2246703", "1000206808", "3036649420", "1000306617", "3006198300", "2915274", "3004987297", "3000210620", "2517506", "3007981058", "3000308930", "2050010", "3009212837", "3011559327", "2020952", "3012073813", "1000442352", "3003795116", "3013679502", "3023322455", "3034694973", "3001452245", "3005670738", "3003610499", "1910144", "3004175381", "3011989923", "3008416529", "3010800486", "3004635103", "1832216", "3008517993", "3005333358", "3030648160", "1000125596", "3010852191", "3012963943", "3004493545", "3012725363", "3005641941", "3006078362", "3010825766", "3009414546", "3031697086", "3013684380", "3013982035", "3006305917", "3002806559", "2050012", "3024463179", "3002642396", "3008852306", "3001451797", "3007838093", "3026478115", "3009238284", "1050155", "3011522054", "2250051", "3017904598", "3030413233", "3021186226", "3007126977", "3010220539", "3005174594", "3006048451", "3008987086", "3009585529", "3023296261", "1220972", "1000140026", "3010939897", "1827821", "3000215862", "3014607865", "3009473156", "3000719950", "3002806560", "3026478116", "3007606081", "3016609999", "1000136573", "3002346973", "1000305841", "3005984081", "3003917514", "3010934853", "3005345870", "3003102569", "3043127647" ], "device_name": "Enzyme Immunoassay, Benzodiazepine", "medical_specialty_description": "Clinical Toxicology", "regulation_number": "862.3170", "device_class": "2" } } ] }