Date of Enforcement Report 12/20/2017
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.
Recall Number Z-0235-2018
Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
Normand Informatique, France on 10/162017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally