REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager coll

FDA device recall Z-2834-2026 · posted 2026-07-31 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Biomedical GmbH

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JQP

Quantity affected

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.

Date initiated

2026-04-29

Date posted

2026-07-31

Location

Munchen, Germany