Events

Retiro De Equipo (Recall) de STACLOT LA 20 IVD REAGENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por STAGO CANADA LTD./STAGO CANADA LTEE.

¿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
    135267
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-02-04
  • 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
    Internal investigations have determined that certain lots of the roduct were marketed in canada utilizing the incorrect reference number and consequently without proper registration with health canada (unlicenced device). however there is an equivalent product utilizing a different reference that is properly registered with health canada. there is no functional difference between the two product reference numbers with the exception of the number of tests that can be conducted.

Device

STACLOT LA 20 IVD REAGENT
  • Modelo / Serial
    Model Catalog: 0594 (Lot serial: 104679); Model Catalog: 0594 (Lot serial: 104449); Model Catalog: 0594 (Lot serial: 102788); Model Catalog: 58230 (Lot serial: 8047402); Model Catalog: 58230 (Lot serial: 7086966); Model Catalog: 58230 (Lot serial: 7117121); Model Catalog: 58230 (Lot serial: 8047411); Model Catalog: 58230 (Lot serial: 8027323); Model Catalog: 58230 (Lot serial: 8027328); Model Catalog: 58230 (Lot serial: 8047404); Model Catalog: 58230 (Lot serial: 8027325); Model Catalog: 58230 (Lot serial: 8047409); Model Catalog: 58230 (Lot serial: 8047401); Model Catalog: 58230 (Lot serial: 8017261); Model Catalog: 58230 (Lot serial: 8027317); Model Catalog: 58230 (Lot serial: 7086963)
  • Descripción del producto
    STACLOT LA 20
  • Manufacturer
    STAGO CANADA LTD./STAGO CANADA LTEE

Manufacturer

STAGO CANADA LTD./STAGO CANADA LTEE