{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220227", "product_res_number": "Z-2834-2026", "event_date_initiated": "2026-04-29", "event_date_posted": "2026-07-31", "recall_status": "Open, Classified", "res_event_number": "98927", "product_code": "JQP", "product_description": "REMISOL Advance with Software Version 2.5\nUDI-DI code: 15099590802073\n\nThe Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections", "code_info": "Software Version 2.5\nUDI-DI code: 15099590802073", "firm_fei_number": "3006677029", "recalling_firm": "Beckman Coulter Biomedical GmbH", "address_1": "Sauerbruchstr. 50 50 sauerbruchstr.", "city": "Munchen", "country": "Germany", "reason_for_recall": "Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.", "root_cause_description": "Under Investigation by firm", "action": "On 04/29/2026, an \"UREGENT MEDICAL DEVICE RECALL\" Letter was sent via email and postal informing customers that, Beckman Coulter has identified a defect in Remisol Advance Software version 2.5 when the system is configured with the Generic-Astm Driver.\nCombo test results are not correctly reported by the software.\nThe issue affects the following assays run on DxI9000 analyzers:\n\"Access HIV Ag/Ab combo (PN C39450)\n\"Access HBsAg Confirmatory (US PN D22915; OUS PN C39425)\n\nCustomers are instructed to:\nIf you are using Remisol Advance version 2.5:\n\"Immediately review your system configuration (instrument driver for the DxI 9000) and verify that the driver is set to Legacy-Astm (please refer to Annex 1 of this letter for information on how to verify the driver settings);\na-If driver is set to Legacy-Astm, no further action is needed;\nb-If the driver is not set as Legacy-Astm:\n-Stop immediately the auto-validation of combo tests in Remisol and contact your Beckman Coulter representative or technical support for further instructions and assistance.\n-Review previously released HIV Ag/Ab combo and HBsAg Confirmatory results, and verify that all sub-results were available for the final result. If they are not available, review the corresponding records on the DxI 9000 Test Results page to identify potentially impacted results.\n-If the relevant sample data are not available on the DxI 9000 Test Results page, the laboratory should consult with the ordering clinician to determine whether specimen recollection and repeat testing are clinically appropriate.\n-Follow laboratory procedures to amend reports as needed, if an incorrect result was issued.\n\"Beckman Coulter recommends posting this letter on or near the affected analyzers.\n\nBeckman Coulter is targeting Q3 2026 for release software update 2.6 to correct this issue.\n\nFor questions - contact Customer Support Center from website http://www.beckmancoulter.com", "product_quantity": "20 systems", "distribution_pattern": "U.S.: FL, GA, IL, MI, and PA\n\nO.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.", "openfda": 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