BEUDAMED
    FDA Enforcement Class II 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 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-1013-2013
    Event ID
    64327
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 3, 2013
    Initiation Date
    February 6, 2013
    Classification Date
    March 27, 2013
    Termination Date
    October 30, 2013
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320, United States

    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.

    Code Info

    lot number: 540274420

    Distribution

    Distributed only in HI.

    Quantity

    4/20-card cartons