Events

Retiro De Equipo (Recall) de Mums The One One Step hCG Urine Pregnancy Test

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mums The One.

¿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-00244-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-04
  • 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-00244-1
  • 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
    Testing undertaken by the tga for the above batch of 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 10miu/ml or 25mlu/ml can be detected".Batch 20151106 failed to detect hcg in human urine at concentrations of 10miu/ml, and 25miu/ml and 50miu/ml levels.False negative results in the worst case can result in misdiagnosis, which can have significant consequences.
  • Acción
    Customers are advised to quarantine any unused stock from the affected batch and contact Mums The One to arrange for the return of the affected stock and a refund. If you suspect that you may have used a Mums The One one step hCG pregnancy test from the affected batch, it is recommended that you retest with a different product.

Device

Mums The One One Step hCG Urine Pregnancy Test
  • Modelo / Serial
    Mums The One One Step hCG Urine Pregnancy TestBatch Number: 20151106 ARTG Number: 152301
  • Manufacturer
    Mums The One

Manufacturer

Mums The One
  • Source
    DHTGA