Recall Z-2834-2026 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Biomedical GmbH
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
| Date | Jul 31, 2026 (initiated Apr 29, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 (ins |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.