Events

Retiro De Equipo (Recall) de Hydrochloric Acid 6 Molar 30mL Containers. 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 Thermo Fisher Scientific 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-2018-RN-00489-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-05-17
  • 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-2018-RN-00489-1
  • 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
    Thermo fisher scientific has identified that the plain container patient information label adhered to specimen jars for specific lots is incorrect as it contains the phrase "10% neutral buffered formalin". the correct label is exactly the same, but without the "10% neutral buffered formalin" phrase. the product information on the box (contains the containers) and content label on the containers are correct.
  • Acción
    Thermo Fisher is advising customers to identify and quarantine affected product. Thermo Fisher will contact users to arrange replacement or credit of stock.

Device

Hydrochloric Acid 6 Molar 30mL Containers. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Hydrochloric Acid 6 Molar 30mL Containers. An in vitro diagnostic medical device (IVD)Catalogue Number: FNNHCL/30Lot Numbers: 1708249410 and 1803258790ARTG Number: 243713(Thermo Fisher Scientific Australia - Specimen receptacle IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd