Z-2834-2026Class II

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

Name: Z-2834-2026 REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data...
Creator: Beckman Coulter Biomedical GmbH
Published: 2026-04-29
License: https://open.fda.gov/license/

Beckman Coulter Biomedical GmbH / initiated 2026-04-29 / Open, Classified / root cause: software

FDA source

Beckman Coulter Biomedical GmbH began a recall of 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... on 2026-04-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2834-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-29
Posted: 2026-07-31
Recalling firm: Beckman Coulter Biomedical GmbH
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
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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 tag: software
FDA 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 (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.
Product codes and lots: Software Version 2.5 UDI-DI code: 15099590802073

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2834-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2834-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)