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REMISOL Advance recallZ-2834-2026 · Beckman Coulter Biomedical GmbH · initiated Apr 29, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beckman Coulter Biomedical GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2834-2026
Status
Open, Classified
Initiated by the company
Apr 29, 2026
Posted by the FDA
Jul 31, 2026
Recalling firm
Beckman Coulter Biomedical GmbH
Quantity
20 systems
Product code
JQP
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 description

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 (models, lots, serial numbers)

Software Version 2.5 UDI-DI code: 15099590802073

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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