FDAFDA · Food and drugs·Recall number Z-0235-2018
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.
Published December 20, 2017 · Recall initiated: October 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Normand Informatique
- Distributor
- Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia
- Lot
- Version 1.6-1.9
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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