BEUDAMED
    FDA Enforcement Class II Terminated

    VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

    Recall: Z-1534-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1534-2020
    Event ID
    84993
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2020
    Initiation Date
    February 5, 2020
    Classification Date
    March 20, 2020
    Termination Date
    October 28, 2022
    Address
    100 Rodolphe St, N/A, Durham, NC, 27712-9402, United States

    Description

    VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

    Reason

    The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.

    Code Info

    REF: 422024 Lot Number: 0210932204

    Distribution

    International distribution in the countries of Germany and the Netherlands.

    Quantity

    4,130 kits (82,600 cards)