{ "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": 1 } }, "results": [ { "cfres_id": "159878", "product_res_number": "Z-0418-2018", "event_date_initiated": "2017-11-14", "event_date_created": "2018-01-26", "recall_status": "Completed", "res_event_number": "78608", "product_code": "DKZ", "k_numbers": [ "K973784" ], "product_description": "Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of\nWash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box.\n\nProduct Usage:\nThe Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.", "code_info": "Lots 403111, 406741, 396588, 398577, 396587", "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": "Technical Services\n858-805-2000 Ext. 3015", "reason_for_recall": "The recalled lots have demonstrated unexpected false positive THC results.", "root_cause_description": "Nonconforming Material/Component", "action": "All primary consignees will be contacted in letter provided via fax, email or direct mail. End users will be instructed to discard any remaining inventory they may have of the affected lots. Alere will provide credit to end users for any remaining unused inventory.", "product_quantity": "2940 units", "distribution_pattern": "Worldwide distribution - United States Nationwide and the countries of Japan, Canada", "openfda": { "k_number": [ "K001225", "K182738", "K033094", "K012745", "K874273", "K994237", "K760936", "K113046", "K011499", "K970395", "K053337", "K994395", "K002447", "K141532", "K990681", "K233019", "K121339", "K152269", "K905700", "K152590", "K992033", "K023104", "K983699", "K842674", "K900995", "K020313", "K032575", "K181945", "K080057", "K023712", "K061617", "K981504", "K121065", "K910658", "K033743", "K053032", "K062077", "K041743", "K833579", "K130811", "K131811", "K874836", "K871696", "K020395", "K182719", "K121987", "K903993", "K930690", "K053175", "K992918", "K874486", "K123863", "K131653", "K071489", "K052882", "K950135", "K041696", "K021006", "K890886", "K010564", "K091588", "K240670", "K874274", "K033659", "K131069", "K992632", "K130463", "K141748", 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