Events

Retiro De Equipo (Recall) de PregSure Digital Pregnancy Test & Pregsure Pregnancy Test. An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Genesis Biotech Pty 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
    RC-2017-RN-00230-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-27
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00230-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Genesis biotech pty ltd has been advised that testing by thetga has identified that two batches of pregsure digital pregnancy test strips and pregsure pregnancy test strips were not sensitive to hcg at 25 miu/ml. consequently, these batches are being recalled.
  • Acción
    Pharmacies are to inspect stocks and quarantine all units from the affected batches. Genesis Biotech will arrange for the quarantined stock to be recovered and replacement stock or a credit note to be issued.

Device

PregSure Digital Pregnancy Test & Pregsure Pregnancy Test. An in vitro diagnostic medical device ...
  • Modelo / Serial
    PregSure Digital Pregnancy Test & Pregsure Pregnancy Test. An in vitro diagnostic medical device (IVD).PregSure Digital Pregnancy TestCatalogue Number: LS-620Batch Number: 16D119-1100PregSure Pregnancy Test (midstream)Catalogue Number: LS-633Batch Number: 16D119-0000ARTG Number: 236402
  • Manufacturer
    Genesis Biotech Pty Ltd

Manufacturer

Genesis Biotech Pty Ltd