Events

Retiro De Equipo (Recall) de Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent used for the isolation of HLA Class II+ cells from human peripheral blood)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life Technologies Australia 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-2014-RN-00416-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-08
  • 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-00416-1
  • 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 manufacturer of dynabeads hla class ii, life technologies as, advises that the listed lots have decreased antibody performance and may not isolate sufficient levels of hla class ii cells required for further testing. lot 142281200 is still within specification, however testing has indicated that it might lose reactivity prior to its expiry date.
  • Acción
    Life Technologies is requesting their customers to inspect their stock and dispose of all units from the affected lots. Lot 142281200 can continue to be used until replacement stock is available.

Device

Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent ...
  • Modelo / Serial
    Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent used for the isolation of HLA Class II+ cells from human peripheral blood)Catalogue Number: 21004DLot Numbers: 135384110 (Expiry Date: 09/2014)142281200 (Expiry Date: 02/2015)ARTG Number: 212748
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd