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.
Enforcement
- Recall Number
- Z-0235-2018
- Event ID
- 78394
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Normand Informatique
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 20, 2017
- Initiation Date
- October 16, 2017
- Classification Date
- December 13, 2017
- Termination Date
- February 13, 2024
- Address
- Normand Informatique, Sci Git; 57 Grand place; Cs 10451, Arras CEDEX, N/A, N/A, France
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.
Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
Version 1.6-1.9
Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia
34 units