{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "214693", "product_res_number": "Z-2266-2025", "event_date_initiated": "2025-06-25", "event_date_posted": "2025-08-05", "recall_status": "Open, Classified", "res_event_number": "97162", "product_code": "JJE", "k_numbers": [ "K023764" ], "product_description": "UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100", "code_info": "UDI-DI: 15099590265373;\nSerial Numbers: 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"firm_fei_number": "2122870", "recalling_firm": "Beckman Coulter, Inc.", "address_1": "1000 Lake Hazeltine Dr", "city": "Chaska", "state": "MN", "postal_code": "55318-1037", "additional_info_contact": "Ian Pilcher\n952-448-4848", "reason_for_recall": "Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.", "root_cause_description": "Device Design", "action": "An URGENT MEDICAL DEVICE RECALL notification dated 6/25/25 was sent to customers.\n\nACTION:\nIf your laboratory encounters any of the events described in this letter:\n\" Perform a system initialization to resume normal operation.\no If repeated initialization attempts fail, contact Customer Technical Support.\n\" Repeat testing for any cancelled tests.\n\" No action is required if your laboratory has not observed the events listed above\n\nESOLUTION:\n\"A Beckman Coulter representative will schedule the modification installation when it is available.\n\nPlease share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter.\n\nSo that we are assured you have received this important communication, please respond within 10 days in one of the following ways:\n\" Electronically, if you received this communication via email.\n\" Manually, complete and return the enclosed Response Form.\nIf you have any questions regarding this notice, please contact our Customer Support:\n\" From our website: http://www.beckmancoulter.com", "product_quantity": "2203 systems", "distribution_pattern": "Worldwide distribution - US Nationwide.", "openfda": { "k_number": [ "K780464", "K922680", "K840501", "K860021", "K961142", "K924084", "K855196", "K800085", "K841503", "K862235", "K942364", "K802609", "K890183", "K883209", "K885226", "K823762", "K863531", "K843059", "K813102", "K882914", "K800572", "K802835", "K834521", "K840120", "K893776", "K760642", "K942443", "K073370", "K833448", "K885288", 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