BEUDAMED
    FDA Enforcement Class II Terminated

    VITEK 2 AST-N351 Test Kit

    Recall: Z-0847-2019 · Reported February 27, 2019

    Enforcement

    Recall Number
    Z-0847-2019
    Event ID
    81953
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2019
    Initiation Date
    December 13, 2018
    Classification Date
    February 16, 2019
    Termination Date
    August 16, 2021
    Address
    100 Rodolphe St, Durham, NC, 27712-9402, United States

    Description

    VITEK 2 AST-N351 Test Kit

    Reason

    False Positive ESBL Phenotype

    Code Info

    Ref: 421257 ALL LOTS

    Distribution

    UK and Ireland

    Quantity

    30,292 cartons (20 cards per carton)