Events

Retiro De Equipo (Recall) de Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. 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 Thermo Fisher Scientific Australia & New Zealand.

¿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-00380-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-05
  • 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-00380-1
  • 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
    Investigations by the manufacturer remel europe, part of thermo fisher scientific, have confirmed that this batch of group b reagent may produce weak or slow reactions. continued use of this batch may result in a failure to identify beta-haemolytic streptococci group b isolates potentially leading to a delay in result reporting and/or a delay to delivering appropriate therapy.
  • Acción
    Laboratories are requested to cease using and destroy the kits containing the affected reagent. This action has been closed-out on 08/08/2016.

Device

Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. An in vitr...
  • Modelo / Serial
    Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. An in vitro diagnostic medical device (IVD)Remel PathoDx Strep Grouping Kit 60 Test (R62025) Lot 1470133 Remel PathoDx Strep B Group Latex Lot 1437729ARTG number: 235676
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand