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Terminated

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.

FDA Recall Z-0235-2018 · Posted None

Recalling FirmNormand Informatique
Recall StatusTerminated
Product CodeJQP
Date Initiated2017-10-16
Date Terminated2024-02-13
Product Quantity34 units

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.

Firm Action

Beckman Coulter sent an Urgent Medical Device Recall letter dated October 16, 2017, to all affected customers. Beckman Coulter has identified a potential issue due to a software nonconformity which could occur after a default service setting (NoCondition) is manually changed from off to on, potentially causing results outside of analytical range to be erroneously displayed. For further questions, please call (800) 526-3821.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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