BEUDAMED
    FDA Enforcement Class II Terminated

    MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

    Recall: Z-2599-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2599-2018
    Event ID
    80330
    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
    August 8, 2018
    Initiation Date
    May 4, 2018
    Classification Date
    August 2, 2018
    Termination Date
    August 7, 2020
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

    Reason

    The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.

    Code Info

    Lot 2018-11-03

    Distribution

    NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA

    Quantity

    686 boxes