Events

Retiro De Equipo (Recall) de Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Conceiveplease 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-2016-RN-00190-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-23
  • 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-2016-RN-00190-1
  • 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
    The testing undertaken by the tga for the above batch of conceiveplease one step hcg urine pregnancy test has shown that this batch does not comply with the claim in the instructions for use which specify that "ln less than 5 minutes, levels of hcg as low as 25mlu/ml can be detected".Batch 20131203 failed to detect hcg in human urine at concentrations of 10 and 25miu/ml levels. false negative results in the worst case can result in misdiagnosis, which can have significant consequences. the tga is undertaking further investigations to ascertain if any further actions are required.
  • Acción
    Please note that ConceivePlease Pty Ltd has advised the TGA that only fewer than 100 kits from the affected batch were supplied to retailers during a three week period, from 21 January to 11 February 2016. Customers are advised to quarantine any unused stock from the affected batch and return them to the place of purchase for a refund. For more information please see http://www.tga.gov.au/alert/conceiveplease-one-step-hcg-urine-pregnancy-test . This action has been closed-out on 19/01/2017.

Device

Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)
  • Modelo / Serial
    Conceiveplease One Step HCG Urine Pregnancy test(Included in ConceivePlease Kits)Batch Number: 20131203Expiry Date: 12 September 2016ARTG Number: 212074
  • Manufacturer
    Conceiveplease Pty Ltd

Manufacturer

Conceiveplease Pty Ltd
  • Source
    DHTGA