Events

Retiro De Equipo (Recall) de Device Recall VITEK 2 XL

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Biomerieux Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2768-2011
  • Fecha de inicio del evento
    2011-06-02
  • Fecha de publicación del evento
    2011-07-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100767
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Susceptibility test cards, antimicrobial - Product Code LTW
  • Causa
    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.
  • Acción
    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 XL
  • Modelo / Serial
    VTK2XL2129 and VTK2XL3250
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228). || 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
  • Dirección del fabricante
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA