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MEDICAL DEVICE RECALLMODERATE

REMISOL Advance Data Manager

Beckman Coulter recalls REMISOL Advance Data Manager over software error that may misreport combo assay results.

What to do

Contact Beckman Coulter Biomedical GmbH for instructions on updating the software to correct the issue.

Recalled
Listed
Updated
Recall No.
Z-2834-2026
Agency
FDA
Firm
Beckman Coulter Biomedical GmbH
Recall ID
98927
Status
ONGOING

Recall at a glance

Quantity recalled
20 systems

Why it was recalled

Beckman Coulter Biomedical GmbH is recalling REMISOL Advance Data Manager with Software Version 2.5 due to a software issue that may incorrectly replace combo assay results with sub-results, leading to incorrect reporting of test outcomes.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Where it was sold

Distributed in Florida, Georgia, Illinois, Michigan, and Pennsylvania.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Software Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-02 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification