Events

Retiro De Equipo (Recall) de One Step HCG Urine 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 Murray International Trading 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-00024-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-08
  • 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-00024-2
  • 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
    Subsequent to complaints regarding false negative results by the users, results of the testing undertaken by the tga for the above batches have showed that these batches do not comply with the claim in the instructions for use which specify that “in less than 5 minutes, levels of hcg as low as 25miu/ml can be detected”. batch # 20150314 has failed to detect hcg in human urine at concentrations of 10, 25, and 50 miu/ml levels while batch # 20140406 has failed at hcg concentrations of 10, 25, 50 and 100 miu/ml . the tga is undertaking further investigation to ascertain if any further actions are required.False negative results in the worst case can result in misdiagnosis and significant harm.
  • Acción
    Customers are advised to quarantine any unused stock from the above batches and return it to Murray International Trading Pty Ltd.

Device

One Step HCG Urine Pregnancy Test. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    One Step HCG Urine Pregnancy Test. An in vitro diagnostic medical device (IVD)Batch Numbers: 20140406 and 20150314ARTG number: 260088
  • Manufacturer
    Murray International Trading Pty Ltd

Manufacturer

Murray International Trading Pty Ltd
  • Source
    DHTGA