Events

Retiro De Equipo (Recall) de Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries(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 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-2015-RN-00084-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-30
  • 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-2015-RN-00084-1
  • 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 a material change made by the supplier has resulted in capillary caps that are more difficult to apply to the capillaries. attempting to apply these capillary caps to the capillaries could result in spillage of the sample or possible breakage of the glass capillary.
  • Acción
    Siemens is advising the customers that they use caution when applying the Capillary Caps with Siemens Multicap glass and Multicap-S plastic capillaries to minimize the potential for breakage or bending. Siemens will be providing new Capillary Caps for the capillary blood collection products by February / March 2015. This action has been closed-out on 20/04/2017.

Device

Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries(An in v...
  • Modelo / Serial
    Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries(An in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10311053, 10311054 and 10328655Legacy Part Number: 478601, 478605 and 478527ARTG number: 174701
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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