{ "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": "203296", "product_res_number": "Z-0107-2024", "event_date_initiated": "2023-09-12", "event_date_posted": "2023-10-12", "recall_status": "Open, Classified", "res_event_number": "93023", "product_code": "JJE", "k_numbers": [ "K221225" ], "product_description": "DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic", "code_info": "UDI/DI 15099590732103, All DxI 9000 Access Immunoassay Analyzer running software version 1.15 or prior", "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": "Adam Viitala\n714-993-5321", "reason_for_recall": "The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with\nthe results of sample B.", "root_cause_description": "Software design", "action": "Beckman Coulter notified its consignees on 09/12/2023 via letter. The notice explained the issue, risk, and consignees were advised to perform a retrospective review of all results that were generated on a DxI 9000 analyzer that is connected to a host system (laboratory information system or middleware).\nCurrent customers should perform one of the following:\nOption 1: Disconnect the DxI 9000 Access\nImmunoassay Analyzer from the host system. You may continue ordering tests through the analyzer console.\nOption 2: Prevent the host system from downloading test orders or sending new information updates to the analyzer.\nBeckman Coulter will release system software version 1.15.2, which prevents reporting an erroneous test result. Test results will still be delayed when the DxI 9000 Access Immunoassay Analyzer may incorrectly identify samples.", "product_quantity": "36 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the state of Florida, and the countries of Croatia, Czechia, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.", "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", 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