Events

Retiro De Equipo (Recall) de Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated with the coagulation cascade) (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-2013-RN-00904-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-08-26
  • 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-2013-RN-00904-1
  • 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
    During recent investigations, siemens healthcare diagnostics has observed that the affected lots have shown reduced on board stability while used on bcs/bcs xp system or sysmex ca-7000 system as demonstrated by testing appropriate controls e.G. berichrom heparin control 1. the complaints received indicate that there is the potential for invalid runs. although unlikely, it is possible that an erroneously low heparin value may be reported which may trigger a higher dose of heparin therapy which could increase the risk of bleeding.
  • Acción
    Siemens Healthcare is advising users to discard any remaining inventory of these lots. Affected lots will be replaced by Siemens Healthcare with unaffected stock. Siemens is not recommending lookback of previously reported Berichrom Heparin results since coagulation status changes over time.

Device

Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated ...
  • Modelo / Serial
    Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated with the coagulation cascade) (An in vitro diagnostic medical device (IVD))Catalogue Number: OWLD 11Siemens Material Number: 10446620Lot Numbers: 42007, 42082, 42483 and 42569ARTG Number: 178506
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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