Events

Retiro De Equipo (Recall) de ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). 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 Abacus ALS 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-00978-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-25
  • 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-00978-1
  • 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
    Abacus are informing users regarding an issue regarding immunocap specific ige control h vial lot cyyac. precipitates have been identified in the affected vials and kit lots. if samples containing precipitates are used, an increased frequency of functional disturbances (error messages e.G. clot error etc.) is to be expected in the instruments. occurrence of precipitate in the control, such as in vial lot cyyac, could give an increased frequency of functional disturbances in the instruments. however, in-house studies undertaken by the manufacturer show no indication that the ige results would be affected by the precipitates.
  • Acción
    Abacus is advising users to inspect stock and discard any remaining kits of the affected lots. Affected product will be replaced by unaffected lots. This action has been closed out on 13 Jun 2017

Device

ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro di...
  • Modelo / Serial
    ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro diagnostic medical device (IVD)Kit Article Number: 10-9530-01Kit Lot Numbers: JBWA, JEXGVial Lot Number: CYYACARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd