{ "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": "190645", "product_res_number": "Z-0404-2022", "event_date_initiated": "2021-11-30", "event_date_created": "2021-12-21", "recall_status": "Terminated", "event_date_terminated": "2023-01-06", "res_event_number": "89150", "product_code": "DIF", "product_description": "Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605", "code_info": "Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250.", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Kassandra Cotner\n866-359-1704", "reason_for_recall": "Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.", "root_cause_description": "Storage", "action": "The firm distributed an Urgent Recall Notification, dated 11/30/2021, to customers who purchased recalled product via first class mail. The notification informs customers that the firm is initiating a removal of Trilevel Serum Matrix Free from S-O2460605 kits due to product being compromised during shipment. Customers are instructed to immediately check their stock for affected product, quarantine any lot numbers associated with the recall, and destroy affected product. Customers were provided an Urgent Remedial Action Destruction Form to complete and return to the firm to indicate whether or not they possess recalled product and document product destruction. Completed forms are to be returned to the firm via email at recalls@medline.com or by fax at 866-767-1290. If product was further distributed, customers are required to share the recall notification down the distribution chain. Customers with any questions about the recall are instructed to call 866-359-1704.", "product_quantity": "14 units (individual)", "distribution_pattern": "US Nationwide distribution in the states of IL, OH, MS, and PA.", "openfda": { "k_number": [ "K012741", "K040758", "K042865", "K822777", "K843818", "K041561", "K881989", "K873467", "K901270", "K831737", "K852414", "K800887", "K833794", "K893682", "K881991", "K843679", "K830518", "K782128", "K843508", "K830494", "K843161", "K060417", "K962165", "K800886", "K080183", "K810504", "K072721", "K863388", "K934498", "K840921", "K934650", "K942114", "K843913", "K121143", "K883190", "K942041", "K820468", "K810468", "K132688", "K153474", "K802854", "K961724", "K050682", "K982024", "K811618", "K992395", "K012319", "K943999", "K820462", "K895816", "K021414", "K934062", "K892380", "K935285", "K874757", "K883210", "K860919", "K093577", "K800885", "K931125", "K810078", "K914806", "K955153", "K990377", "K012999", "K936166", "K911167", "K132174", "K880444", "K820191", "K955155", "K802672", "K983387", "K911168", "K871694", "K844945", "K831741", "K080085", "K954291", "K925586", "K844946", "K103656", "K800883", "K853933", "K831278", "K831500", "K830492", "K032826", "K884178", "K880445", "K811809", "K831740", "K950138", "K861970", "K880145", "K953739", "K980871", "K810235", "K970666", "K063398", "K964771", "K982217", "K120504", "K971060", "K873037", "K952056", "K890030", "K021411", "K823746", "K964422", "K983127", "K903909", "K033924", "K893835", "K813349", "K022707", "K012907", "K932643", "K052053", "K870586", "K931105", "K903189", "K800889", "K821950", "K913309", "K910930", "K954322", "K982649", "K905457", "K871788", "K802278", "K841439", "K901271", "K911724", "K952412", "K881944", "K803097", "K803039", "K935230", "K980331", "K811756", "K914170", "K951817", "K910333", "K945194", "K942257", "K954799", "K930269", "K913650", "K780960", "K811811", "K932549", "K800882", "K121122", "K971691", "K972819", "K971534", "K821973", "K834259", "K812950", "K021384", "K810077", "K904905", "K942551", "K983709", "K880512", "K060788", "K943422", "K831734", "K940433", "K862817", "K960244", "K033404", "K800884", "K860097", "K890957", "K041666", "K920477", "K873183", "K013002", "K821975", "K873539", "K953845", "K803036", "K981590", "K021415", "K831736", "K942552", "K820296", "K033366", "K050037", "K972174", "K951135", "K830234", "K965157", "K890406", "K881990", "K900626", "K062191", "K880152", "K971058", "K800888" ], "registration_number": [ "2432235", "1649661", "3010127294", "1319808", "2050012", "3003610499", "2030633", "3010939897", "1827821", "3002642396", "3002809144", "3004175381", "3006198300", "1616487", "3014607865", "9610126", "1050155", "3008156187", "2250051", "1032263", "2517506", "2022375", "1932270", "3000308930", "1319681", "3003593973", "3005333358", "2050010", "3012963943", "2030861", "1220649", "2020952", "9610529", "3001431095", "3004493545", "2060833", "3003795116", "2016706", "2432495", "3013982035", "2319772" ], "fei_number": [ "2432235", "3010127294", "3001452245", "3002806559", "2050012", "3003610499", "3010939897", "1827821", "3002642396", "3002809144", "3004175381", "3006198300", "3000215862", "3001451797", "1616487", "1000521247", "3014607865", "1000119187", "1050155", "3002806560", "3008156187", "2250051", "3000210620", "1000136573", "1032263", "2517506", "1000305841", "2022375", "3000308930", "3003593973", "3005333358", "2050010", "3012963943", "3004493545", "1220649", "2020952", "3001431095", "3003795116", "2016706", "2432495", "3013982035" ], "device_name": "Drug Mixture Control Materials", "medical_specialty_description": "Clinical Toxicology", "regulation_number": "862.3280", "device_class": "1" } } ] }