OVERLOOKED

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Class IIOngoing

Beckman Coulter Biomedical GmbH recalls REMISOL Advance with Software Version 2

Recall date · record updated Aug 12, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Beckman Coulter Biomedical GmbH
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Florida, Georgia, Illinois, Michigan, Pennsylvania
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98927…

Products

  1. 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

    Codes/lots: Software Version 2.5 UDI-DI code: 15099590802073Quantity: 20 systemsRecall no. Z-2834-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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