Events

Retiro De Equipo (Recall) de FB REAGENT

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
    27779
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-03-07
  • 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
    During the stability study of a new batch of zym b reagent (70493) a visual defect has been observed. after three months of stability this batch presents an heterogeneous aspect of color from yellow to red (a color yellow to amber is considered as conform according to the package insert). this visual defect is due to a specific new batch of raw material (lot mkbp5202v of fast blue bb salt sigma) used for the manufacturing of several batches of fb reagent and zym b reagent. as the involved batches of zym b reagent are included inside of api nh (10400) and api listeria (10300) kits the both references are also impacted.

Device

FB REAGENT
  • Modelo / Serial
    Model Catalog: 70562 (Lot serial: 1002717180); Model Catalog: 10400 (Lot serial: 1002869721); Model Catalog: 10400 (Lot serial: 1002869720); Model Catalog: 10400 (Lot serial: 1002826750); Model Catalog: 10400 (Lot serial: 1002814891); Model Catalog: 10400 (Lot serial: 1002814890); Model Catalog: 10400 (Lot serial: 1002809140); Model Catalog: 10400 (Lot serial: 1002786740); Model Catalog: 10300 (Lot serial: 1002856800); Model Catalog: 10300 (Lot serial: 1002856790); Model Catalog: 10300 (Lot serial: 1002587190); Model Catalog: 10300 (Lot serial: 1002569041); Model Catalog: 10300 (Lot serial: 1002569040); Model Catalog: 70493 (Lot serial: 1002860530); Model Catalog: 70493 (Lot serial: 1002857840); Model Catalog: 70493 (Lot serial: 1002821420); Model Catalog: 70493 (Lot serial: 1002760700); Model Catalog: 70493 (Lot serial: 1002742610); Model Catalog: 70493 (Lot serial: 1002717860); Model Catalog: 70493 (Lot serial: 1002706740); Model Catalog: 70562 (Lot serial: 1002877370); Model Catalog: 70562 (Lot serial: 10
  • Descripción del producto
    FB REAGENT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.