BEUDAMED
    FDA Enforcement Class II Terminated

    PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

    Recall: Z-0023-2013 · Reported October 17, 2012

    Enforcement

    Recall Number
    Z-0023-2013
    Event ID
    63019
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2012
    Initiation Date
    August 28, 2012
    Classification Date
    October 9, 2012
    Termination Date
    September 4, 2014
    Address
    595 Anglum Rd, N/A, Hazelwood, MO, 63042-2320, United States

    Description

    PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

    Reason

    The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.

    Code Info

    Serial numbers AS180-00001 to AS180-00376.

    Distribution

    Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.

    Quantity

    350 systems