Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Recalled by Normand Informatique Due to Beckman Coulter has identified that due to a...

Date: October 16, 2017
Company: Normand Informatique
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Normand Informatique directly.

Affected Products

Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.

Quantity: 34 units

Why Was This Recalled?

Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.

Where Was This Sold?

Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia

About Normand Informatique

Normand Informatique has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report