BEUDAMED
    FDA Recall 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.

    Recall: Z-0235-2018 · Initiated October 16, 2017

    Recall

    Recall Number
    Z-0235-2018
    Event Number
    78394
    Firm
    Normand Informatique Normand Informatique Sci Git; 57 Grand place; Cs 10451 Arras CEDEX France
    FEI Number
    3006543086
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 16, 2017
    Terminated
    February 13, 2024

    Description

    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

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

    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.

    Distribution

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

    Quantity

    34 units