Events

Recall of Device Recall VITEK 2 60

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomerieux Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58981
  • Event Risk Class
    Class 2
  • Event Number
    Z-2767-2011
  • Event Initiated Date
    2011-06-02
  • Event Date Posted
    2011-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100766
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Susceptibility test cards, antimicrobial - Product Code LTW
  • 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.

Device

Device Recall VITEK 2 60
  • Model / Serial
    VTK23119 to VTK 23745
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Biomerieux Inc

Manufacturer

Biomerieux Inc
  • Manufacturer Address
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA