Events

Retiro De Equipo (Recall) de ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - FOSFOMYCIN

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
    33638
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-12-28
  • 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
    As a part of an ongoing project regarding the analysis of stability data on etest range we have observed a decrease in the shelf life of the following etest products that requires your immediate attention to ensure improved use of the product within its revised shelf life of (24) months.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - FOSFOMYCIN
  • Modelo / Serial
    Model Catalog: 529108 (Lot serial: More than 10 contact manuf.); Model Catalog: 513610 (Lot serial: More than 10 contact manuf.); Model Catalog: 512518 (Lot serial: More than 10 contact manuf.); Model Catalog: 512510 (Lot serial: More than 10 contact manuf.); Model Catalog: 506718 (Lot serial: More than 10 contact manuf.); Model Catalog: 535918 (Lot serial: More than 10 contact manuf.); Model Catalog: 529100 (Lot serial: More than 10 contact manuf.); Model Catalog: 513618 (Lot serial: More than 10 contact manuf.); Model Catalog: 525518 (Lot serial: More than 10 contact manuf.); Model Catalog: 525510 (Lot serial: More than 10 contact manuf.); Model Catalog: 522718 (Lot serial: More than 10 contact manuf.); Model Catalog: 502518 (Lot serial: More than 10 contact manuf.); Model Catalog: 508618 (Lot serial: More than 10 contact manuf.); Model Catalog: 508610 (Lot serial: More than 10 contact manuf.)
  • Descripción del producto
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - FOSFOMYCIN FM 1024 WW;ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - IMIPENEM IP 32 WW;ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - GENTAMICIN GM 256 WW;ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFTAZIDIME TZ
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.