{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "112909", "product_res_number": "Z-0059-2013", "event_date_initiated": "2012-07-06", "event_date_posted": "2012-10-12", "recall_status": "Terminated", "event_date_terminated": "2012-11-15", "res_event_number": "63191", "product_code": "JJE", "k_numbers": [ "K042291", "K060256", "K103842" ], "product_description": "Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853.\n\nProduct Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).", "code_info": "Serial Numbers: 547-574 (UCTA)", "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": "Clair K. O'Donovan, Ph.D.\n714-961-4483", "reason_for_recall": "The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial numbers between 547 and 574 may cause a hardware motion error (ID0x08000501).", "root_cause_description": "Nonconforming Material/Component", "action": "The recall notification was initiated on July 6, 2012 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form to all customers who purchased the UniCel DxC 880i, UniCel DxC 860i, UniCel 680i, UniCel DxC 660i Clinical System Integrated Workstations UCTA Sample Syringe Pump Drive Assembly. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Beckman Coulter will schedule a Service Call to replace the affected sample syringe pump drive assemblies. Customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any questions regarding the PCA, were instructed to call Customer Support at (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact Beckman Coulter Representative.", "product_quantity": "18 units", "distribution_pattern": "Worldwide Distribution and US (nationwide) and the countries of China, France, Italy and Taiwan.", "openfda": { "k_number": [ "K873130", "K971761", "K882081", "K802609", "K840501", "K882559", "K861055", "K780083", "K840129", "K772319", "K841916", "K831649", "K930489", "K863531", "K830762", "K860647", "K883209", "K953239", "K802835", "K965240", "K945271", "K110035", "K042169", "K073370", "K970227", "K813160", "K926060", "K842500", "K823386", "K002982", "K832648", "K800053", "K853003", "K931744", "K843283", "K800572", "K950353", "K924084", "K843059", "K844114", "K885226", "K843082", "K130276", "K923579", "K893776", "K832584", "K942364", "K131554", "K912844", "K931786", "K782014", "K821335", "K933548", "K780388", "K860748", "K950958", "K923060", "K833116", "K862235", "K903071", "K855196", "K950915", "K922220", "K884378", "K831518", 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