BEUDAMED
    FDA Enforcement Class II Terminated

    Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.

    Recall: Z-1717-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1717-2020
    Event ID
    84759
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sysmex America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2020
    Initiation Date
    January 21, 2020
    Classification Date
    April 15, 2020
    Termination Date
    January 30, 2023
    Address
    1 Sysmex Way, Mundelein, IL, 60060-9528, United States

    Description

    Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.

    Reason

    When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.

    Code Info

    Serial Numbers: 11201, 11202, 12310, 12311, 12312, 12313, 12941, 12942, 12997, 13875, 14170, 14171, 14172, 14173, 14174, 14175, 14278, 14279, 14280, 14962, 14963, 14964, 14965, 14966, 14967, 14968, 14969, 14970, 14972, 14973, 14974, 14975, 14976, 14977, 14978, 14979, 15017, 15018, 15619, 15620

    Distribution

    USA: FL, VT, IL.

    Quantity

    40 units