{ "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": 13 } }, "results": [ { "cfres_id": "177823", "product_res_number": "Z-0692-2020", "event_date_initiated": "2019-02-15", "event_date_posted": "2019-12-17", "recall_status": "Terminated", "event_date_terminated": "2021-04-28", "res_event_number": "84239", "product_code": "DJG", "k_numbers": [ "K022355" ], "product_description": "QuickTox 5 Panel Drug Screen DipCard", "code_info": "Catalog Number: QT11 Lot Number: 188787", "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": "Angela Occhionero\n858-805-8943", "reason_for_recall": "Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)", "root_cause_description": "Labeling mix-ups", "action": "On February 15, 2019, the firm sent a \"FIELD CORRECTIVE ACTION NOTIFICATTION\" via email (read receipt requested), and/or via certified mail with delivery tracking to its customers informing them of mixed products, QuickTox 5 Panel Drugs Screen Dipcard, part number QT11 with lot number 188787 containing Alere iScreen Drugs of Abuse Dip Test, part number X11-IS10-22015-DX lot number 188744. Customer are being requested to return the affected products and if products were further distributed customers are to notify those customers and request for return of affected products.\nIn addition, all customers receiving the notice are asked to complete and return the included \"Customer Verification Form\" via fax 888-340-4029.", "product_quantity": "3400 units (136 kits)", "distribution_pattern": "US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX.\n\nOUS - None", "openfda": { "k_number": [ "K200197", "K935346", "K992422", "K240698", "K230238", "K993491", "K935117", "K203527", "K192943", "K881941", "K050733", "K130275", "K141205", "K172910", "K203564", "K880010", "K913863", "K000273", "K110298", "K163101", "K220451", "K000851", "K924446", "K063699", "K012483", "K090844", "K131168", "K143599", "K013407", "K053037", "K033047", "K031032", "K201326", "K240124", "K001178", "K991883", "K041144", "K040316", "K994234", "K971361", "K161216", "K042990", "K120763", "K013314", 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