{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "221550", "product_res_number": "Z-2973-2026", "event_date_initiated": "2026-07-15", "event_date_posted": "2026-08-17", "recall_status": "Open, Classified", "res_event_number": "99436", "product_code": "JJE", "k_numbers": [ "K242190" ], "product_description": "Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: \n1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; \n2) DxC 500 AU Module, DxC 500i, Part Number C63521; \n3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers", "code_info": "1) Part Number C63522, UDI/DI 14987666545089; \n2) Part Number C63521, UDI/DI 14987666545072; \n3) Part Number C13252, UDI/DI 15099590742331.", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "additional_info_contact": "Ian Pilcher\n443-350-6459", "reason_for_recall": "a software defect in which the Parameter Package (PP)\nimport logic overwrites all predefined calculated test rules, including those previously\nmodified by the user, upon import of a new Parameter Package version. As a result, usercustomized\ncalculated test rules revert silently to their default expressions, potentially\ngenerating erroneous patient test results without an explicit error notification. The issue affects\ninstruments running software version 1.5 or lower and only occurs when a new Parameter\nPackage is imported to a system that already has an existing Parameter Package onboard; new\ninstallations are not affected.", "root_cause_description": "Software design (manufacturing process)", "action": "Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice (dated 7/10/26) to its consignees on 7/15/2026 via USPS and/or email. The notice explained the issue, impact, and requested the following: \nThe customers are advised to:\n\" Do not change any of the 25 predefined calculated rules. In the case that the default expression does not meet the laboratory s requirements, Beckman Coulter has developed a Job Aid, which outlines the workflow required if laboratories require calculated test rules outside of those predefined calculated rules.\n\" Consult with the Laboratory Manager and/or Medical Director to determine whether any of the predefined rules in the table were modified from the default expression during or following analyzer installation.\n o If no default expression was modified, there is no action to be taken.\n o If a predefined calculated rule was modified as compared with the default expressions in the table, follow the steps in the letter to configure this rule as a custom calculated rule in System configuration and to disable the predefined calculated rule that was modified.\n\" Share the letter with the Medical Director to determine if performing a retrospective review of results is necessary.\n\" Post the letter on or near the affected analyzers. \nFor questions regarding this notice, please contact our Customer Support Center.\n \" From our website: http://www.beckmancoulter.com\n \" By phone: call 1-800-854-3633 in the United States and Canada. \n o Outside the United States and Canada, contact your local Beckman Coulter representative.", "distribution_pattern": "Worldwide distribution - US Nationwide.", "openfda": { "k_number": [ "K904220", "K813102", "K882194", "K851638", "K860748", "K003721", "K890928", "K810549", "K870833", "K922220", "K840868", "K854243", "K882451", "K945566", "K863531", "K183375", "K853699", "K883209", "K942922", "K922072", "K961142", "K802835", "K051087", "K820687", "K862818", "K113253", "K901003", "K883533", "K811194", "K833067", "K790072", "K853003", "K831649", "K885226", "K923060", "K912844", "K852133", "K883539", "K780083", "K872104", "K920402", "K771245", "K931786", "K781076", "K963539", "K801889", "K843610", "K834534", "K800085", "K882559", "K951189", "K821335", "K810596", "K942443", "K872103", 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"1415939", "3005643513", "1827821", "2915274", "3010825766", "3007662974", "3016244760", "1000136573", "2122870", "3001644026", "2050012", "3006198300", "3002808212", "3007361513", "3002808340", "1000305841", "3023268435", "3017098905", "2967", "3027977508", "3029973107", "3017019647", "3037000637", "3034707949", "3017548799", "3003261083", "1000455123", "1181121", "3004434309" ], "device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2160", "device_class": "1" } } ] }