Normand Informatique recalls Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Ma…

Recall date

October 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0235-2018

FDA classification

Class II

Brand / firm

Normand Informatique

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.