{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "159406", "product_res_number": "Z-0235-2018", "event_date_initiated": "2017-10-16", "event_date_created": "2017-12-13", "recall_status": "Terminated", "event_date_terminated": "2024-02-13", "res_event_number": "78394", "product_code": "JQP", "product_description": "Remisol Advance Software (Driver Architect) Catalog Number B32129\n\nThe Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.", "code_info": "Version 1.6-1.9", "firm_fei_number": "3006543086", "recalling_firm": "Normand Informatique", "address_1": "57 normand informatique sci git grand place cs 10451 arras", "city": "CEDEX", "country": "France", "additional_info_contact": "Beckman Coulter representative\n800-526-3821", "reason_for_recall": "Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.", "root_cause_description": "Software design", "action": "Beckman Coulter sent an Urgent Medical Device Recall letter dated October 16, 2017, to all affected customers.\n\nBeckman Coulter has identified a potential issue due to a software nonconformity which could occur after a default service setting (NoCondition) is manually changed from off to on, potentially causing results outside of analytical range to be erroneously displayed.\n\nFor further questions, please call (800) 526-3821.", "product_quantity": "34 units", "distribution_pattern": "Worldwide Distribution - 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