Events

Retiro De Equipo (Recall) de INNOVANCE PFA P2Y. An in vitro diagnostic 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 Siemens Healthcare 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-00019-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-01-07
  • 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-00019-1
  • 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
    Siemens healthcare diagnostics has confirmed that innovance pfa p2y cartridge lots 5464024, 5464025, 5464026 and 5464027 show falsely extended shelf life.Internal investigations have shown that innovance pfa p2y cartridges used beyond the correct but within the displayed shelf life date showed a maximal deviation of down to -11% which is within the overall performance claims. there is no risk to health.
  • Acción
    The sponsor is advising users not to use units from the affected lots beyond the correct shelf life dates given in the customer letter. This action has been closed-out on 27/01/2017.

Device

INNOVANCE PFA P2Y. An in vitro diagnostic device (IVD)
  • Modelo / Serial
    INNOVANCE PFA P2Y. An in vitro diagnostic device (IVD)Catalogue Number: B4170-22Siemens Material Number (SMN): 10445700Lot Numbers: 5464024; 5464025; 5464026; 5464027ARTG Number: 178507
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA