{ "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": "151041", "product_res_number": "Z-0722-2017", "event_date_initiated": "2016-11-10", "event_date_posted": "2016-12-08", "recall_status": "Terminated", "event_date_terminated": "2017-04-17", "res_event_number": "75681", "product_code": "DIS", "k_numbers": [ "K001976" ], "product_description": "Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate)\n\nProduct is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.", "code_info": "Lot # 6654085", "firm_fei_number": "2528909", "recalling_firm": "OraSure Technologies, Inc.", "address_1": "1745 Eaton Ave", "city": "Bethlehem", "state": "PA", "postal_code": "18018-1769", "additional_info_contact": "Jose L. Rosado\n610-882-1820 Ext. 1657", "reason_for_recall": "Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.", "root_cause_description": "Mixed-up of materials/components", "action": "Due to the small number of customers that were affected by the recall, OraSure notified customers on November 10, 2016, via telephone with a follow-up email. Customers were asked to quarantine the units on hand and they will schedule a pickup by Fed EX to retrieve the affected units.\n\nFor further questions, please call (610) 882-1820, ext. 1657", "product_quantity": "4 kits", "distribution_pattern": "Distributed to KS, and VA", "openfda": { "k_number": [ "K962669", "K920314", "K926068", "K001976", "K882611", "K902580", "K151211", "K140215", "K010125", "K934376", "K161714", "K991018", "K890690", "K925491", "K014089", "K992451", "K890884", "K810602", "K041712", "K961010", "K991082", "K973047", "K942436", "K043211", "K033334", "K802617", "K062165", "K874702", "K936030", "K950137", "K882663", "K070009", "K032764", "K010934", "K070098", "K944075", "K874210", "K020136", "K840194", "K002331", "K874483", "K000459", "K150791", "K012996", "K982745", "K110515", "K842783", "K991084", "K951253", "K833577", "K941489", "K960664", "K931535", "K974712", "K982152", "K892650", "K042975", "K092268", "K000522", "K002337", "K874266", "K012133", "K955928", "K842675", "K870936", "K050024", "K933480", "K896550", "K942404", "K870378", "K963529", "K041143", "K905057", "K980349", "K920525", "K010561", "K143535", "K050593", "K991440", "K982551", "K873623", "K010959", "K012824", "K920417", "K792114", "K003647", "K843418", "K983698", "K991076", "K953021", "K140665", "K935116", "K990280", "K903825", "K873754", "K880012", "K033885", "K945344", "K023946", "K864993" ], "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", "3008416529", "3010800486", "3004635103", "1832216", "3008517993", "8020888", "2087033", "3005333358", "3030648160", "3010852191", "3012963943", "3004493545", "3012725363", "3005641941", "3010825766", "2060833", "3031697086", "3013684380", "3013982035", "3006305917", "2031229", "2050012", "2030633", "3024463179", "3002642396", "3008852306", "1219913", "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", "3026478116", "3007606081", "3016609999", "3005984081", "3003917514", "3010934853", "3005345870", "3043127647", "3033967997" ], "fei_number": [ "", "2432235", "3027519599", "2246703", "3036649420", "1000306617", "3006198300", "2915274", "3004987297", "3000210620", "2517506", "3007981058", "3000308930", "2050010", "3009212837", "3011559327", "2020952", "3012073813", "1000442352", "3003795116", "3013679502", "3023322455", "3034694973", "3001452245", "3005670738", "3003610499", "1910144", "3004175381", "3008416529", "3010800486", "3004635103", "1832216", "3008517993", "3005333358", "3030648160", "1000125596", "3010852191", "3012963943", "3004493545", "3012725363", "3005641941", "3006078362", "3010825766", "3007019572", "3031697086", "3013684380", "3013982035", "3006305917", "3002806559", "2050012", "3024463179", "3002642396", "3008852306", "3001451797", "1219913", "3007838093", "3026478115", "3009238284", "1050155", "3011522054", "2250051", "3017904598", "3030413233", "3021186226", "3007126977", "3010220539", "3005174594", "3006048451", "3008987086", "3009585529", "3023296261", "1220972", "3010939897", "1827821", "3000215862", "3014607865", "3000719950", "3002806560", "3026478116", "3007606081", "3016609999", "1000136573", "3002346973", "1000305841", "3005984081", "3003917514", "3010934853", "3005345870", "3003102569", "3043127647", "3033967997" ], "device_name": "Enzyme Immunoassay, Barbiturate", "medical_specialty_description": "Clinical Toxicology", "regulation_number": "862.3150", "device_class": "2" } } ] }