Events

Retiro De Equipo (Recall) de COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por OXOID COMPANY.

¿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
    42405
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-13
  • 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
    A technical investigation has identified oxoid columbia blood agar base cm0331t lot 1857212 used to make prepared media mp035 i various batches (annex i) may not provide acceptable microbiological performance when supplemented with whole horse or sheep blood. recovery is lower than typically expected and haemolvsis may be reduced atypical or absent.

Device

COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD
  • Modelo / Serial
    Model Catalog: MP0351 (Lot serial: 1886256); Model Catalog: MP0351 (Lot serial: 1871520); Model Catalog: MP0351 (Lot serial: 1884738); Model Catalog: MP0351 (Lot serial: 1884143); Model Catalog: MP0351 (Lot serial: 1884144); Model Catalog: MP0351 (Lot serial: 1884142); Model Catalog: MP0351 (Lot serial: 1885371); Model Catalog: MP0351 (Lot serial: 1885370); Model Catalog: MP0351 (Lot serial: 1882604); Model Catalog: MP0351 (Lot serial: 1882599); Model Catalog: MP0351 (Lot serial: 1881777); Model Catalog: MP0351 (Lot serial: 1881776); Model Catalog: MP0351 (Lot serial: 1881775); Model Catalog: MP0351 (Lot serial: 1881070); Model Catalog: MP0351 (Lot serial: 1881069); Model Catalog: MP0351 (Lot serial: 1881068); Model Catalog: MP0351 (Lot serial: 1878943); Model Catalog: MP0351 (Lot serial: 1878942); Model Catalog: MP0351 (Lot serial: 1878183); Model Catalog: MP0351 (Lot serial: 1878182); Model Catalog: MP0351 (Lot serial: 1878181); Model Catalog: MP0351 (Lot serial: 1878140); Model Catalog: MP0351 (Lot serial
  • Descripción del producto
    COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD
  • Manufacturer
    OXOID COMPANY

Manufacturer

OXOID COMPANY