FDAOctober 16, 2017device

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 cap...

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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