FDA recall Z-0235-2018

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 for recall

Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.

Distribution

Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia

Key facts

Status

Terminated

Initiation date

2017-10-16

Report date

2017-12-20

Termination date

2024-02-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arras CEDEX, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0235-2018