Class 2 Device Recall REMISOL Advance

• Date Initiated by Firm: April 29, 2026
• Date Posted: July 31, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2834-2026
• Recall Event ID: 98927
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
• Code Information: Software Version 2.5 UDI-DI code: 15099590802073
• FEI Number: 3006677029
• Recalling Firm/ Manufacturer: Beckman Coulter Biomedical GmbH; Sauerbruchstr. 50; Munchen Germany
• Manufacturer 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.
• FDA Determined Cause: 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. Combo test results are not correctly reported by the software. The issue affects the following assays run on DxI9000 analyzers: "Access HIV Ag/Ab combo (PN C39450) "Access HBsAg Confirmatory (US PN D22915; OUS PN C39425) Customers are instructed to: If you are using Remisol Advance version 2.5: "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); a-If driver is set to Legacy-Astm, no further action is needed; b-If the driver is not set as Legacy-Astm: -Stop immediately the auto-validation of combo tests in Remisol and contact your Beckman Coulter representative or technical support for further instructions and assistance. -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. -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. -Follow laboratory procedures to amend reports as needed, if an incorrect result was issued. "Beckman Coulter recommends posting this letter on or near the affected analyzers. Beckman Coulter is targeting Q3 2026 for release software update 2.6 to correct this issue. For questions - contact Customer Support Center from website http://www.beckmancoulter.com
• Quantity in Commerce: 20 systems
• Distribution: U.S.: FL, GA, IL, MI, and PA O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.