Device 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.
Z-0235-2018
Product summary
- Event
- Event 78394
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34 units
- Official record key
device-enforcement:Z-0235-2018
Official wording
Reason: Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
Code information: Version 1.6-1.9
Distribution pattern: Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia
Derived failure modes
-
Device software or design
software nonconformity in connection with a changed service setting Remisol could