Events

Retiro De Equipo (Recall) de VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BIOMERIEUX CANADA 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
    111383
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-02-22
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Internal investigation has demonstrated that in specific cases when a card is processed in and ejected from a slot number greater than 15 or 30 (all vitek 2 compact reader carousels contain 60 physical slots) respectively the final data packet for the card fails to be accepted by the computer and the isolate status remains at "preliminary". when the anomaly occurs subsequent data for current and future cards will not be transferred to the computer until the offending data packet is removed. since the card has completed processing as evidenced by the card ejection from the vitek 2 compact reader the results indicated in the lab report are the final results. as the card data for the ejected card will be lost after record removal it is recommended the user print the lab report prior to removal of the record.

Device

VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
  • Modelo / Serial
    Model Catalog: 27530 (Lot serial: All)
  • Descripción del producto
    VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.