Events

Retiro De Equipo (Recall) de TREMBLAY HARRISON MINUTE LAB STREP A RAPID TEST DEVICE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por WHOLESALE MEDICAL NETWORK 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
    38601
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-10-09
  • 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
    Tremblay harrison is a private label manufacturer of the stw-a1. we were notified on september 182011 by the manufacturer innovacon inc. that they are undertaking a voluntary recall of the tests as they have discovered an elevated incidence of false positive results. a false positive result could lead to the administration of antibiotics that are unnecessary. this exposes the patient to potential side effects or allergic reaction. these are rarely serious and are usually resolved with discontinuation of medication. as with all diagnostic tests all results must interpreted together with other clinical information available to the physician. the health hazard evaluation has concluded that the overall health risk is low.

Device

TREMBLAY HARRISON MINUTE LAB STREP A RAPID TEST DEVICE
  • Modelo / Serial
    Model Catalog: STW-A1 (Lot serial: STA0110106); Model Catalog: STW-A1 (Lot serial: STA0110011); Model Catalog: STW-A1 (Lot serial: STA0010072); Model Catalog: STW-A1 (Lot serial: STA0100087)
  • Descripción del producto
    Tremblay Harrison Minute Lab Strep A Rapid Test
  • Manufacturer
    WHOLESALE MEDICAL NETWORK INC.

Manufacturer

WHOLESALE MEDICAL NETWORK INC.
  • Dirección del fabricante
    TORONTO
  • Source
    HC