{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "217570", "product_res_number": "Z-1025-2026", "event_date_initiated": "2025-11-26", "event_date_posted": "2026-01-06", "recall_status": "Open, Classified", "res_event_number": "98070", "product_code": "JJE", "k_numbers": [ "K121790" ], "product_description": "Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; \tImmunoassay Method, Troponin Subunit", "code_info": "A71460: UDI 15099590369224\nA71461: UDI 15099590369248\nA30260: UDI 15099590341602", "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 determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.", "root_cause_description": "Device Design", "action": "Beckman Coulter issued an \"URGENT MEDICAL DEVICE RECALL\" notice dated 11/19/2026 to its consignees on 11/26/2025 via US mail and email. The notice explained the issue, impact, and requested the following actions: \n-Follow the restart process documented in Section 2 of the \"Unicel DxI Access Immunoassay System Instructions for Use.\"\n-If your analyzer continues to experience this issue, please contact Beckman Coulter Technical Support.\n-Beckman Coulter recommends posting this letter on or near the affected analyzers.\" \n- Please 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 products listed above to another laboratory, please provide them a copy of this letter.\" \n\nFor questions: please contact Customer Support Center: http://www.beckmancoulter.com", "product_quantity": "1272 units", "distribution_pattern": "Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India\nIndonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of,\nKosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.", "openfda": { "k_number": [ "K112999", "K813102", "K883321", "K902689", "K951189", "K130276", "K945271", "K834534", "K840129", "K873130", "K863531", "K841076", "K885288", "K832648", "K073370", "K923060", "K844114", "K872813", "K865105", "K810549", "K944093", "K770679", "K890183", "K853391", "K882451", "K903071", "K942922", "K843610", "K872494", "K051087", "K854243", "K965240", "K946090", "K962231", "K862818", "K834521", "K884378", "K790072", "K820888", "K771345", "K893137", "K830301", "K002982", "K841503", "K780083", "K895423", "K872105", "K910185", "K003721", "K854138", "K800053", "K833116", "K780388", 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