Events

Retiro De Equipo (Recall) de Immunoassay Premium and Premium Plus controls when used with ACTH assays. 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 Randox 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-2017-RN-01067-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-21
  • 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-2017-RN-01067-1
  • 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
    Randox has confirmed that acth in immunoassay premium plus quality control and immunoassay premium quality control does not meet the quoted reconstituted stability claim in the product ifu. randox now recommends that acth is to be assayed immediately after the 30-minute reconstitution procedure.The quality control results which are not within range can lead to a delay in reporting acth results. acth is typically measured to aid in diagnosing the cause of abnormal cortisol. abnormal cortisol levels are generally not associated with immediate life threatening disorders. therefore a delay in acth reporting is unlikely to pose a serious risk to health.
  • Acción
    1. Place a copy of the supplied notice in all impacted control kits, advising to assay ACTH immediately after the reconstitution procedure is complete. 2. Discuss the contents of the notice with the Medical Director.

Device

Immunoassay Premium and Premium Plus controls when used with ACTH assays. An in vitro diagnostic ...
  • Modelo / Serial
    Immunoassay Premium and Premium Plus controls when used with ACTH assays. An in vitro diagnostic medical device (IVD)Immunoassay Premium Quality ControlsCatalogue Number: IA2633Lot Numbers: 402366, 398703Immunoassay Premium Plus Quality ControlsCatalogue Number: IA3109 Lot Numbers: 1573EC, 1619EC Catalogue Number: IA3110 Lot Number: 1477ECCatalogue Number: IA3111 Lot Numbers: 1478EC, 1578ECCatalogue Number: IA3112Lot Number: 377412, 398901ARTG Number: 206767
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA