Events

Retiro De Equipo (Recall) de Thermo Scientific MAS Omni-IMMUNE PRO. 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.

¿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-00024-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-15
  • 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-2014-RN-00024-1
  • 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
    The constituent, inhibin a, was removed for mas omni-immune and mas omni-immune pro controls; however the package insert was not updated to reflect removal. the affected lots should not be used as control material for monitoring inhibin a assays. no other analytes of the mas omni-immune and mas omni-immune pro controls are affected.This action was undertaken prior to approval of the recall strategy by the tga.
  • Acción
    Thermo Fisher Scientific is advising users to destroy any remaining stock of the affected lot numbers. An alternative product is available for use by affected users.

Device

Thermo Scientific MAS Omni-IMMUNE PRO. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Thermo Scientific MAS Omni-IMMUNE PRO. An in vitro diagnostic medical device (IVD) Catalogue Numbers: OPRO-101, OPRO-202, OPRO-303, OPRO -SPLot Numbers: OPRO15101, OPRO15102, OPRO15103, OPRO1510S
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific