Events

Retiro De Equipo (Recall) de RAPIDQC Complete Solution Level 3. 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 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-00470-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-19
  • 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-00470-1
  • 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 identified that the ph parameter may recover low within range or lower than expected with the affected lots of level 3 rapidqc complete product on both the rapidpoint and the rapidlab blood gas systems. the issue identified represents a negligible risk to patients and does not pose any health or safety risk to operators.
  • Acción
    Siemens is advising users that if the QC values are recovering within range, the lots can continue to be used. If the affected lots are not recovering within range, the lots will be replaced with unaffected stock.

Device

RAPIDQC Complete Solution Level 3. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    RAPIDQC Complete Solution Level 3. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10309927Lot Numbers: 363403, 363404, 363501ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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