Events

Retiro De Equipo (Recall) de EasyCheck Pregnancy Test Cassette

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Hangzhou Clongene Biotech Co Ltd.

¿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
    18808
  • Fecha de inicio del evento
    2015-07-03
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Phoenix MedCare Limited, 25K Garnet Road, Westmere, Auckland 1022
  • Causa
    Individual test pouches have a misprint in the results illustration under heading "invalid" showing an"invalid" result to be equal to a "negative" result., a negative result may be interpreted as an invalid result if the ifu not consulted., , , our product is supplied in boxes of 40 tests, and an ifu is included with each box. the pouch printing was a feature we have introduced on the new funded product, as an improvement to the previous tender holder (blank pouches).
  • Acción
    Product to be modified

Device

EasyCheck Pregnancy Test Cassette

Manufacturer

Hangzhou Clongene Biotech Co Ltd