Events

Retiro De Equipo (Recall) de Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER-AW endoscope reprocessing cycle)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Saraya Australia 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-00139-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-27
  • 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-00139-1
  • 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
    During storage the acecide test strips may have been stored outside the manufacturer recommended 2-8°c for longer than 14 days. as a result, the shelf life of the test strips may be affected. use of test strips that have not been stored according to the recommended conditions may alert users to change the acecide solution more often than required.
  • Acción
    Customers are advised to check their inventory, quarantine, and dispose of any acecide test strips within their control. They will be provided with replacement stock for any affected inventory. Customers are also advised to ensure that the test strips must be stored between 2-8°C and that the test strip be used only after being brought to room temperature. This action has been closed-out on 01/03/2018.

Device

Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER...
  • Modelo / Serial
    Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER-AW endoscope reprocessing cycle)All stock currently in the marketARTG number: 170540
  • Manufacturer
    Saraya Australia Pty Ltd

Manufacturer

Saraya Australia Pty Ltd