Events

Retiro De Equipo (Recall) de NUCLISENS EASYMAG LYSIS BUFFER

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
    72657
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-03-06
  • 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
    The risk to use the product beyond the expiration date due to the incorrect label is to have false results. the severity level of the risk to obtain false results (due to the insufficient extraction) has been assessed as critical considering that the product is used in the extraction phase of the nuclisens and r-gene tests and it is also used always in the extraction phase in association with other kits not manufactured by biomerieux. medical affairs confirmed the severity of the issue as critical for adverse health consequences and mitigated the occurrence as remote (unlikely to occur but is possible).

Device

NUCLISENS EASYMAG LYSIS BUFFER
  • Modelo / Serial
    Model Catalog: 280134 (Lot serial: Z014GA1LB)
  • Descripción del producto
    NUCLISENS EASYMAG LYSIS BUFFER
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.