BEUDAMED
    FDA Enforcement Class II Terminated

    The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

    Recall: Z-2166-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2166-2018
    Event ID
    80111
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMerieux SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    March 23, 2018
    Classification Date
    June 12, 2018
    Termination Date
    June 23, 2020
    Address
    Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, N/A, France

    Description

    The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

    Reason

    A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.

    Code Info

    VITEK¿ 2 ANC (ref: 21347): Lot Number 2440318203

    Distribution

    International distribution.

    Quantity

    135 (78 boxes of various product) in total