{ "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": 10 } }, "results": [ { "cfres_id": "122244", "product_res_number": "Z-0053-2014", "event_date_initiated": "2013-09-23", "event_date_posted": "2013-10-23", "recall_status": "Terminated", "event_date_terminated": "2014-09-26", "res_event_number": "66394", "product_code": "DIF", "k_numbers": [ "K060788" ], "product_description": "Alere Triage TOX Drug Screen Control 1\n\nProduct Generic Name: Quality Control Material\n\nDescription of the product:\nGood Laboratory Practice suggests that external controls should be tested with each new lot or shipment\nof test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control\nprocedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures\ndescribed in the Alere Triage TOX Drug Screen package insert, provide this capability. The results\nobtained for the controls are to be compared with the assigned values given on the Expected Values Card,\naccompanying the package insert, to determine if the procedure is within control limits.\nAlere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of\nhuman urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse.\n\n510(k)/IDE/PMA number: K060788\n\nType of Packaging: 5 vials per level in a labeled kit box.\n\nIndications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.", "code_info": "Part Number 94413. Lot Number C2681A.", "firm_fei_number": "1000125596", "recalling_firm": "Alere San Diego, Inc.", "address_1": "9975 Summers Ridge Rd", "city": "San Diego", "state": "CA", "postal_code": "92121-2997", "additional_info_contact": "858-805-2000 Ext. 3015", "reason_for_recall": "Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.", "root_cause_description": "Under Investigation by firm", "action": "Alere San Diego, Inc. sent an Urgent Medical Device Notice dated September 23, 2013, to all affected customers via FedEx and outside US (OUS) consignees on September 24, 2013, via email. The customer notification letter titled \"URGENT MEDICAL DEVICE NOTICE\", informed customers of the recall, product description with part number and lot code (Alere Triage TOX Drug Screen Control 1 PN 94413 Lot C2681A), reason for recall and impact (The purpose of the letter was to inform customers that the CODE CHIP\" that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screen products. Customers were instructed to discontinue use of and discard the CODE CHIP contained within the Alere Triage TOX Drug Screen Control 1 PN 94413 Lot C2681A kit box. Customers were also instructed to provide a copy of the notice to their customers and instruct them to contact Alere for a replacement code chip. Customers were asked to complete and fax the enclosed Verification Form to confirm their receipt of the notice. Customers with questions were instructed to contact:\n(Alere San Diego, Inc.\n9975 Summers Ridge Road\nSan Diego, CA 92121, U.S.A.\nPhone: 877 308 8287\nFAX: 858 805 8457\nE-mail: Responses.ts@alere.com).\nFor questions regarding this recall call 858-805-2000, ext 3015.", "product_quantity": "38", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.", "openfda": { "k_number": [ "K951817", "K821973", "K962165", "K964771", "K843818", "K120504", "K971058", "K934498", "K881990", "K833794", "K844945", "K840921", "K093577", "K982024", "K830234", "K810235", "K951135", "K080183", "K831741", "K800887", "K153474", "K063398", "K103656", "K800886", "K811809", "K820296", "K942041", "K942552", "K831734", "K870586", "K800883", "K871694", "K911168", "K942114", "K802278", "K861970", "K893835", "K830494", "K914806", "K950138", "K970666", "K800889", "K834259", "K841439", "K830518", "K033366", "K911167", "K901271", "K911724", "K942257", "K803039", "K983127", "K062191", "K953845", "K904905", "K863388", "K843161", "K873539", "K860097", "K782128", "K810468", "K831736", "K925586", "K914170", "K080085", "K041561", "K022707", "K811618", "K780960", "K954799", "K831278", "K980331", "K945194", "K893682", "K952056", "K021411", "K012907", "K964422", "K960244", "K983387", "K881989", "K890957", "K132688", "K913309", "K862817", "K942551", "K021414", "K971060", "K013002", "K873037", "K890406", "K954322", "K803036", "K952412", "K012999", "K955153", "K874757", "K961724", "K042865", "K810504", "K800888", "K953739", "K803097", "K981590", "K820462", "K871788", "K810078", "K041666", "K965157", "K920477", "K033404", "K831500", "K033924", "K844946", "K980871", "K972819", "K813349", "K932643", "K800884", "K810077", "K821975", "K890030", "K943999", "K901270", "K040758", "K860919", "K935285", "K931105", "K932549", "K021415", "K910930", "K831740", "K811811", "K822777", "K052053", "K913650", "K800882", "K873467", "K931125", "K895816", "K060417", "K012319", "K050682", "K990377", "K800885", "K955155", "K910333", "K935230", "K853933", "K823746", "K843913", "K883210", "K936166", "K880445", "K873183", "K883190", "K940433", "K892380", "K072721", "K971534", "K992395", "K982649", "K812950", "K132174", "K843679", "K884178", "K954291", "K802672", "K121143", "K983709", "K802854", "K982217", "K934062", "K943422", "K060788", "K971691", "K021384", "K900626", "K820468", "K880444", "K905457", "K050037", "K972174", "K903189", "K820191", "K012741", "K880512", "K880145", "K881944", "K880152", "K032826", "K811756", "K934650", "K881991", "K852414", "K821950", "K831737", "K903909", "K830492", "K930269", "K121122", "K843508" ], "registration_number": [ "2050012", "3004493545", "3012963943", "1616487", "3003610499", "1319681", "3004175381", "2022375", "1319808", "2319772", "3002809144", "2050010", "1032263", "3001431095", "1649661", "2020952", "9610126", "2250051", "3013982035", "1827821", "2060833", "2517506", "2432495", "3010127294", "2016706", "1220649", "3003795116", "2030861", "3014607865", "3003593973", "3002642396", "1050155", "3008156187", "3005333358", "2030633", "1932270", "2432235", "3000308930", "3006198300", "9610529", "3010939897" ], "fei_number": [ "2050012", "3004493545", "3012963943", "1616487", "3003610499", "3004175381", "2022375", "2050010", "3002809144", "3002806560", "1032263", "3001431095", "2020952", "2250051", "3001452245", "3013982035", "1827821", "3002806559", "2432495", "2517506", "3010127294", "2016706", "1220649", "3003795116", "3014607865", "1000305841", "1000136573", "3000215862", "3003593973", "3002642396", "1050155", "3008156187", "3005333358", "1000521247", "2432235", "3000308930", "3006198300", "3001451797", "1000119187", "3010939897", "3000210620" ], "device_name": "Drug Mixture Control Materials", "medical_specialty_description": "Clinical Toxicology", "regulation_number": "862.3280", "device_class": "1" } } ] }