Events

Retiro De Equipo (Recall) de VITEK MS Clinical Systems. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biomerieux Australia Pty Ltd.

¿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
    RC-2017-RN-00909-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00909-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The vitek ms system could give, in specific conditions, an incorrect identification result if the tested species is not included in the vitek ms knowledge base (kb). when the microorganism tested is not part of the training dataset, no specific species pattern will be available in the database for comparison. consequently, the system can give:1) no identification when the spectrum acquired does not match with any species pattern.2) a low discrimination identification when the spectrum acquired presents a high level of similarity with multiple specific species patterns present in the database.3) an incorrect single choice identification to the nearest pattern species when the spectrum acquired presents a high level of similarity with a specific species pattern present in the database.This is a system limitation with all maldi-tof databases which is currently not described in the user manual.
  • Acción
    Biomerieux is requesting customers: 1. Distribute the supplied information to all appropriate personnel in your laboratory, retain a copy in your files, and forward the customer letter to all parties that may use this product, including others to whom you may have transferred our product; 2. Take this limitation into account; 3. Contact your local Customer Service in case of questions; and 4. Complete and return the supplied Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice

Device

VITEK MS Clinical Systems. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITEK MS Clinical Systems. An in vitro diagnostic medical device (IVD)Reference Number: 410895Software version: V2 / KB CLI_2.0 ex-US Acquisition station: V2.0 : ref 411032ARTG Number: 199422
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd