BEUDAMED
    FDA Recall Terminated

    VITEK 2 System, VITEK 2 60 110V (Catalog #27225) and VITEK 2 60 220V (Catalog #27226). 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 system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.

    Recall: Z-2767-2011 · Initiated June 2, 2011

    Recall

    Recall Number
    Z-2767-2011
    Event Number
    58981
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    LTW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 2, 2011
    Posted
    July 9, 2011
    Terminated
    June 6, 2013
    Address
    595 Anglum Rd, Hazelwood, MO, 63042

    Description

    VITEK 2 System, VITEK 2 60 110V (Catalog #27225) and VITEK 2 60 220V (Catalog #27226). 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 system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.

    Reason

    Cards may not load into the incubator correctly causing them to be loaded in the wrong order which could result in the results being linked to the wrong accession number and reporting results erroneously.

    Action

    Biomerieux, Inc. sent an "URGENT PRODUCT CORRECTION NOTICE" dated June 2, 2011 to all affected customers. The letter describes the products, problem, and actions to be taken by the customers. The letter explains how to recognize the issue and instructs customers to take certain steps to resolve the problem. Additionally, an Acknowledgement Form is attached to the letter for customers to complete and return via fax to 919-314-4539. A firmware update will be applied by Biomerieux, Inc. technical support representatives. Questions regarding this recall are directed to the Customer Service Department at 1-800-682-2666, option 3.

    Distribution

    Worldwide Distribution-- USA (nationwide) and the countries of Austria, Australia, Belgium, Brazil, Canada, China, Colombia, Germany, France, India, Israel, Italy, Japan, Korea, Mexico, The Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirate, and United Kingdom.

    Quantity

    627 instruments