BEUDAMED
    FDA Enforcement Class III Terminated

    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

    Recall: Z-1401-2015 · Reported April 15, 2015

    Enforcement

    Recall Number
    Z-1401-2015
    Event ID
    70645
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 15, 2015
    Initiation Date
    February 25, 2015
    Classification Date
    April 8, 2015
    Termination Date
    March 22, 2017
    Address
    595 Anglum Rd, N/A, Hazelwood, MO, 63042-2320, United States

    Description

    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

    Reason

    The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

    Code Info

    lot 735352820, expiration 11AUG16; lot 735348620, expiration 30JUN16; lot 735346520, expiration 09JUN16; lot 735342320; expiration 28APR16; lot 735318020, expiration 29AUG15; lot 735315920, expiration 08AUG15; lot 735323710, expiration 25OCT15; lot 735310210, expiration 12JUN15

    Distribution

    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.

    Quantity

    10409 cartons