BEUDAMED
    FDA Enforcement Class II Terminated

    iQ200 Series Urine Microscopy Analyzer- All part numbers

    Recall: Z-1945-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1945-2020
    Event ID
    85423
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    March 30, 2020
    Classification Date
    May 8, 2020
    Termination Date
    August 31, 2023
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    iQ200 Series Urine Microscopy Analyzer- All part numbers

    Reason

    A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.

    Code Info

    Catalog Numbers: 00-3322, 700-3325, 700-3326, 700-3345, 700-3347, 700-3370, 700-3375, 700-3300RFB, B48999, C10683, C10684., All part numbers

    Distribution

    US Distribution: Nationwide Foreign Distribution: Worldwide

    Quantity

    3576 units