BEUDAMED
    FDA Recall 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 · Initiated March 2, 2018

    Recall

    Recall Number
    Z-1362-2018
    Event Number
    79566
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    March 2, 2018
    Terminated
    July 6, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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.

    Action

    The customers were contacted initially by the Urgent Medical Device Recall letter on 03/028/2018 delivered by email and US Mail. Beckman Coulter will schedule a sites visit to verify the reporting units of measurement for casts for the laboratory within 90 days of this recall initiation. The use of Casts/HPF is not a common setting worldwide.

    Distribution

    Worldwide

    Quantity

    5247 units