{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214298", "product_res_number": "Z-2073-2025", "event_date_initiated": "2025-06-12", "event_date_posted": "2025-07-02", "recall_status": "Open, Classified", "res_event_number": "97034", "product_code": "DJG", "k_numbers": [ "K062460" ], "product_description": "VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.", "code_info": "Model Number: 680 1997. UDI-DI: 10758750001835. Lot Numbers: 1527-15-2749 (exp. 17-Nov-2025), 1527-15-2771 (exp. 17-Dec-2025), 1527-15-2818 (exp. 11-Apr-2026), 1527-15-2871 (exp. 15-May-2026).", "firm_fei_number": "1000136573", "recalling_firm": "Ortho-Clinical Diagnostics, Inc.", "address_1": "100 Indigo Creek Dr", "city": "Rochester", "state": "NY", "postal_code": "14626-5101", "additional_info_contact": "Laurie O'Riordan\n954-6239546", "reason_for_recall": "Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.", "root_cause_description": "Under Investigation by firm", "action": "Quidel Ortho notified consignees on about 06/12/2025 via FedEx letter. Distributors were instructed to discontinue distribution and discard inventory of any affected lots, send the provided customer letter and Confirmation of Receipt to any affected customers, and complete and return their Confirmation of Receipt.\n\nCustomers were instructed that if their laboratory is unable to generate QC results within acceptable range using lots from GEN 15 of VITROS OP Reagent, discontinue using, render unusable, and discard your inventory of VITROS OP Reagent, GEN 15. Additionally, there were requested to complete and return the Confirmation of Receipt, maintain the notification with all records, and provide the notification if affected units were further distributed.", "product_quantity": "2,017 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.", "openfda": { "k_number": [ "K041144", "K060466", "K231904", "K972405", "K180427", "K013314", "K905491", "K994234", "K140671", "K020716", "K220451", "K112310", "K062460", "K161216", "K974840", "K091612", "K041746", "K143187", "K173195", "K232736", "K921328", "K093175", "K881941", "K843162", "K172910", "K013482", "K992422", "K011150", "K232597", "K101195", "K150179", "K972571", "K102779", "K201938", "K150502", "K151478", "K904997", "K231698", "K973153", 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