{ "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": "112676", "product_res_number": "Z-0123-2013", "event_date_initiated": "2012-09-03", "event_date_posted": "2012-10-24", "recall_status": "Terminated", "event_date_terminated": "2014-02-14", "res_event_number": "63143", "product_code": "JJE", "k_numbers": [ "K042291", "K060256", "K103842" ], "product_description": "UniCel DxC 600/800 with\nSoftware v5.0.11, Part Number B12218.\n\nThe UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled 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": "Part Number B12218. Serial numbers 2329, 5477, 5479.", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "reason_for_recall": "Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment\nprocedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this\nalignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the\nShuttle to Bar", "root_cause_description": "Software change control", "action": "Beckman Coulter sent an Urgent Field Safety Notice dated August 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their Beckman Coulter Service Representative would contac them to reinstall the software. Customers were asked to complete and return the enclosed Response Form. For questions customers were instructed to call their Customers Support Center on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/SupportRequest.\nFor questions regarding this recall call 714-993-5321.", "product_quantity": "7 units total (both US and International)", "distribution_pattern": "Worldwide Distribution - USA including TX and OH. 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"device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2160", "device_class": "1" } } ] }