BEUDAMED
    FDA Enforcement Class II Terminated

    Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.

    Recall: Z-2743-2020 · Reported August 12, 2020

    Enforcement

    Recall Number
    Z-2743-2020
    Event ID
    85693
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Normand-Info S.A.S.U.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 12, 2020
    Initiation Date
    April 30, 2020
    Classification Date
    July 31, 2020
    Termination Date
    February 10, 2022
    Address
    7 rue Frederic Degeorge, Arras CEDEX, N/A, France

    Description

    Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.

    Reason

    Results from repeated run for WBC (White Bloodcell Count), UWBC (Urine Whit Bloodcell Count) and PLT (Platelets) are deleted in RADV. Use may lead to erroneous results.

    Code Info

    All serial numbers

    Distribution

    Worldwide distribution: US (nationwide) including states of: CA, GA, IL, IN, KS, MI, MO, NY, NC, OH, PA, SD, TN, VA, and WV; and countries of: Bahrain, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Israel, Malaysia, Netherlands, Switzerland, Taiwan,Turkey, and United Kingdom.

    Quantity

    663