Events

Retiro De Equipo (Recall) de Berichrom Antithrombin III Kits. 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-00179-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-02-15
  • 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-00179-1
  • 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 some packages of the berichrom antithrombin iii kit may contain a different substrate reagent lot as given in the package labelling. dependent on the instrument used, some instruments with automatic reagent identification may request a new calibration.The correct substrate reagent lot number is 520294. this issue has no impact on patient results.
  • Acción
    Siemens Healthcare is advising users that the affected product will be replaced with unaffected stock. This action has been closed-out on 03/02/2017.

Device

Berichrom Antithrombin III Kits. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Berichrom Antithrombin III Kits. An in vitro diagnostic medical device (IVD)Catalogue Number: OWWR15, OWWR17Siemens Material Number (SMN): 10446672, 10446673Lot Number: 45029, 45027ARTG Number: 178559
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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