Normand Informatique: Medical Device Recall in 2017 - (Recall #: Z-0235-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 16, 2017

Date Posted: December 20, 2017

Recall Number: Z-0235-2018

Event ID: 78394

Reason for Recall:

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

Status: Terminated

Product Quantity: 34 units

Code Information:

Version 1.6-1.9

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated