BEUDAMED
    FDA Recall 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 · Initiated May 4, 2018

    Recall

    Recall Number
    Z-2599-2018
    Event Number
    80330
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    LTT
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 4, 2018
    Terminated
    August 7, 2020
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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.

    Action

    A recall notification letter was sent the week of 05/01/2018 via email, mail, and phone if needed.

    Distribution

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

    Quantity

    686 boxes