{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114075", "product_res_number": "Z-0346-2013", "event_date_initiated": "2011-08-01", "event_date_posted": "2012-11-19", "recall_status": "Terminated", "event_date_terminated": "2012-11-19", "res_event_number": "63505", "product_code": "JJE", "k_numbers": [ "K023764" ], "product_description": "UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461.\n\nThe UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.", "code_info": "Serial Numbers: 900000 through 900491.", "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 UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.", "root_cause_description": "Process design", "action": "Beckman Coulter sent a field modification was released in August 2011 which included:\n- Installing a new aspirate and dispense tubing routing bracket.\n- Replacing existing aspirate and dispense probe tubing with modified tubing to help eliminatemisrouting of aspirate and dispense probe tubing.\n\nDuring installation the FSE informed the customer:\n-That aspirate and dispense tubing are different lengths.\n- That probes are not interchangeable with other instruments once tubing has been modified.\n- To route probe tubing by referring to the labels on the tubing.\n\nAn updated service document, Routine Maintenance Changes, A82294B was provided to every customer.\nFor questions regarding this recall call 714-961-4483.", "product_quantity": "432 units", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR, AT, BE, CO, DZ, FI, IE, IL, KR, KW, LI, NA, NO, NZ, PF, PH, PR, SE, SG, SZ, TH, TW, VE, VN, and YT.", "openfda": { "k_number": [ "K833448", "K930489", "K840868", "K760642", "K882914", "K890184", "K853699", "K950958", "K873617", "K780388", "K912024", "K840129", "K971761", "K813102", "K040958", "K863840", "K851638", "K942443", "K904219", "K963539", "K872104", "K882081", "K832584", "K843283", "K940289", "K884378", "K885289", "K772344", "K860080", "K802835", "K832115", "K853003", "K872813", "K946090", "K912844", "K832648", "K945135", "K792361", "K073370", "K860021", "K820888", "K933703", "K822465", "K885226", "K940810", "K823386", "K842773", "K853391", "K852133", "K112999", "K962235", "K844114", 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