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

Recalled December 20, 2017 · FDA recall Z-0235-2018 · Normand Informatique

Hazard

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

Units

34 units

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Normand Informatique

Made in

France

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →