FDA-Device2017-12-20Class II
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 Ad
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.
Sold states
Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia
Affected count
34 units
Manufactured in
Normand Informatique, Sci Git; 57 Grand place; Cs 10451, Arras CEDEX, N/A, France
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0235-2018Don't want to check this manually?
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