Events

Retiro De Equipo (Recall) de BBL LYSINE IRON AGAR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECTON DICKINSON 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
    17117
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-01-16
  • 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 ph is at 6.2 to 6.3 versus a specification of 6.5 to 6.9. the material contains a ph indicator (bromcresol purple) which is used as part of the mechanism of differentiation. the low ph is causing organisms that should give alkaline reactions to not give the correct reaction two complaints originating in the us (dec 2010 and june 2011) have been filed with the manufacturer in regards to failed ph results. both facilities properly prepared the medium and both found inconsistent performance based on quality control specifications. however proper qc was performed leading the facilities to not use the product.

Device

BBL LYSINE IRON AGAR
  • Modelo / Serial
    Model Catalog: 211363 (Lot serial: 0238264); Model Catalog: 211363 (Lot serial: 0204203); Model Catalog: 211363 (Lot serial: 0132356)
  • Descripción del producto
    BBL Lysine Iron Agar
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.