BEUDAMED
    FDA Recall Terminated

    bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.

    Recall: Z-1013-2013 · Initiated February 6, 2013

    Recall

    Recall Number
    Z-1013-2013
    Event Number
    64327
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LTW
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 6, 2013
    Posted
    March 27, 2013
    Terminated
    October 30, 2013
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.

    Reason

    The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.

    Action

    bioMerieux sent an "PRODUCT SAFETY CORRECTION NOTICE" dated February 13, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at (800) 682-2666 for questions regarding this notice.

    Distribution

    Distributed only in HI.

    Quantity

    4/20-card cartons