FDAClass II · Medical device · Recall Z-2834-2026 · Recalled August 12, 2026

REMISOL Advance with Software Version 2 recall — Beckman Coulter Biomedical GmbH

Agency report date: August 12, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: REMISOL Advance with Software Version 2
Company / brand: Beckman Coulter Biomedical
Lot / serial / date codes: Software Version 2.5 UDI-DI code: 15099590802073
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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: REMISOL Advance with Software Version 2

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2834-2026
Brand: Beckman Coulter Biomedical
Classification: Class II
Units affected: 20 systems
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

REMISOL Advance with Software Version 2

Companies & origin

Recalling firm location: Munchen, Germany
Firm address: Sauerbruchstr. 50, N/A

Identifying details (verbatim from the notice)

Product codes / lots: Software Version 2.5 UDI-DI code: 15099590802073
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.
Firm notified the public via: Letter
FDA event ID: 98927
Recall initiated: April 29, 2026
FDA classified: July 31, 2026
FDA report date: August 12, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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