BEUDAMED
    FDA Enforcement Class II Terminated

    QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.

    Recall: Z-2146-2016 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-2146-2016
    Event ID
    74356
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hardy Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 20, 2016
    Initiation Date
    May 24, 2016
    Classification Date
    July 8, 2016
    Termination Date
    March 3, 2017
    Address
    1430 W McCoy Ln, Santa Maria, CA, 93455-1005, United States

    Description

    QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.

    Reason

    Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.

    Code Info

    All units manufactured between October 2014 and May 2016.

    Distribution

    U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.

    Quantity

    25