BEUDAMED
    FDA Recall 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 · Initiated August 28, 2012

    Recall

    Recall Number
    Z-0023-2013
    Event Number
    63019
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LXG
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    August 28, 2012
    Posted
    October 9, 2012
    Terminated
    September 4, 2014
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    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.

    Action

    bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" letter dated August 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return. Contact Customer Service at 1-800-682-2666 for questions regarding this notice.

    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