BEUDAMED
    FDA Enforcement Class II Terminated

    Biomerieux Vitek 2 Test kit 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.

    Recall: Z-1137-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1137-2019
    Event ID
    82501
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    March 15, 2019
    Classification Date
    April 12, 2019
    Termination Date
    August 17, 2021
    Address
    100 Rodolphe St, N/A, Durham, NC, 27712-9402, United States

    Description

    Biomerieux Vitek 2 Test kit 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.

    Reason

    Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.

    Code Info

    Ref: 413723 (AST-N254), 418674 (AST-N330) and 422024 (AST-N371 Card) with 8.01/9.01 SW Unique Device Identifier: 03573026404550 (AST-N254) / 03573026474836 (AST-N330) / 03573026604363 (AST-N371)

    Distribution

    Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.

    Quantity

    10784 cartons