BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1177-2014 · Initiated February 10, 2014

    Recall

    Recall Number
    Z-1177-2014
    Event Number
    67463
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LIB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 10, 2014
    Posted
    March 12, 2014
    Terminated
    March 16, 2017
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    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.

    Action

    The firm sent a recall notification letter to all of their consignees on 2/10/2014.

    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