BEUDAMED
    FDA Enforcement Class II Terminated

    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370

    Recall: Z-1362-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1362-2018
    Event ID
    79566
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 18, 2018
    Initiation Date
    March 2, 2018
    Classification Date
    April 11, 2018
    Termination Date
    July 6, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    Description

    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370

    Reason

    Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.

    Code Info

    All

    Distribution

    Worldwide

    Quantity

    5247 units