BEUDAMED
    FDA Enforcement Class II Terminated

    bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.

    Recall: Z-1177-2014 · Reported March 19, 2014

    Enforcement

    Recall Number
    Z-1177-2014
    Event ID
    67463
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 19, 2014
    Initiation Date
    February 10, 2014
    Classification Date
    March 12, 2014
    Termination Date
    March 16, 2017
    Address
    595 Anglum Rd, N/A, Hazelwood, MO, 63042-2320, United States

    Description

    bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.

    Reason

    The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.

    Code Info

    Serial number range: AS 180-00001 to AS 180-00476

    Distribution

    Distribution was made to AK, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA and WI.

    Quantity

    471 instruments