Events

Retiro De Equipo (Recall) de QUICKSTEP PLUS ONE STEP URINE PREGNANCY TEST

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INNOVATEK MEDICAL 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
    83034
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-04-24
  • 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
    One end user has recently reported a random finding of anti-hiv tests inside some of the sealed quickstep plus pouches instead of hcg pregnancy tests. any anti-hiv tests found are not usable on their own and will not give any valid result as they lack other test components necessary to perform a test procedure. affected test cassettes have "anti-hiv" prominently embossed next to the reading window are smaller in size than pregnancy tests have a different configuration and lack the blue colour in the sample well that pregnancy test cassettes show. the expiry date is nearing on this lotand that all quickstep plus pregnancy test kits of lot number 04081 must be discarded after april 30 2013.

Device

QUICKSTEP PLUS ONE STEP URINE PREGNANCY TEST
  • Modelo / Serial
    Model Catalog: 4220-33 (Lot serial: 04081)
  • Descripción del producto
    Quickstep Plus one step urine pregnancy test
  • Manufacturer
    INNOVATEK MEDICAL INC.

Manufacturer

INNOVATEK MEDICAL INC.