{ "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": "88235", "product_res_number": "Z-0863-2010", "event_date_initiated": "2010-01-04", "event_date_posted": "2010-03-04", "recall_status": "Terminated", "event_date_terminated": "2012-04-17", "res_event_number": "54344", "product_code": "JJE", "k_numbers": [ "K042291", "K060256" ], "product_description": "Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell.\nPN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i).\n\nIntended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid.", "code_info": "All serial numbers. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel DxC 860i); and A64935 (UniCel DxC 860i).", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "200 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6208", "additional_info_contact": "714-993-5321", "reason_for_recall": "Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results.", "root_cause_description": "Device Design", "action": "An Urgent: Product Corrective Action letter dated January 4, 2010, was mailed to customers advising of erroneous sodium results derived from build up of protein, bacteria and additives in the ISE flow cell. The letter discussed the impact and actions to be taken along with some additional recommendations. Customers are advised to follow the new maintenance instructions included with the letter. The information in the letter should be shared with laboratory staff and the notification should be retained as part of the Quality System documentation. A copy of the letter should be provided to any other laboratory that affected product was forwarded to. The enclosed response form should be completed and returned. 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