Recall Z-0235-2018— Normand Informatique

Class II FDA medical device recall by Normand Informatique, initiated 2017-10-16, terminated 2024-02-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results..

Recalling firm

Normand Informatique

Classification

Class II

Status

Terminated

Initiated

2017-10-16

Terminated

2024-02-13

Firm location

Arras CEDEX, N/A, France

Data sourced from openFDA. This site is unofficial and independent of the FDA.