CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report

Remisol Advance recalled by Beckman Coulter Biomedical

Beckman Coulter Biomedical is recalling Remisol Advance, distributed in Florida, Georgia, Illinois, Michigan, Pennsylvania. The recall was initiated on 29 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Version 2.5 UDI-DI code: 15099590802073

Quantity recalled20 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2834-2026
FDA event ID: 98927
Recalling firm: Beckman Coulter Biomedical, Munchen
Classification: Class II
Status: Ongoing
Recall initiated: 29 Apr 2026
FDA classified: 31 Jul 2026
Reported: 12 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Medical Software

Timeline

29 Apr 2026	Recall initiated by company
31 Jul 2026	Classified by FDA	+93 days
12 Aug 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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 distributed

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.

Florida Georgia Illinois Michigan Pennsylvania

Questions about this recall

Why was it 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.

Which lots are affected?

Software Version 2.5 UDI-DI code: 15099590802073

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Beckman Coulter Biomedical

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