Events

Retiro De Equipo (Recall) de Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay)

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 Ltd Diagnostics Division.

¿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-2014-RN-00873-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-12
  • 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-2014-RN-00873-1
  • 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 have identified that majority of current lots of this product are affected by reduced reagent stability after reconstitution.. affected lots were identified before release during regular quality control processes and became part of an extended testing program to verify reagent stability. there has been no impact on product performance within the reduced stability.
  • Acción
    Siemens is advising end users that reduced in use stability claims will be indicated on a ‘Pink Note’ included with the kits. This action has been closed-out on 31/05/2016.

Device

Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay)
  • Modelo / Serial
    Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay)Affected lot numbers that have been supplied: 539267, 539267B, 539273, 539280, 539281, 539298, 539301, 539303A, 539305, 539306, 539309ARTG Number: 178501
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA