Events

Retiro De Equipo (Recall) de Randox Liquid Assayed Specific Protein Controls. 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-2018-RN-00508-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-31
  • 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-2018-RN-00508-1
  • 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 have confirmed that free kappa light chains in certain liquid assayed specific protein controls increase over the shelf life of the product. the quality control results which are not within range can lead to a delay in reporting free kappa light chains results.Free kappa light chains are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for multiple myeloma through review of the ratio with free lamda chains. a short delay in reporting this result is unlikely to prevent diagnosis of these progressive diseases and therefore is unlikely to pose an immediate risk to health.
  • Acción
    Randox is advising users to be aware of the issue and place the Customer Letter with any remaining kits. A revised IFU is also being supplied to users which outlines this issue to users under "Storage and Stability".

Device

Randox Liquid Assayed Specific Protein Controls. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Randox Liquid Assayed Specific Protein Controls. An in vitro diagnostic medical device (IVD). Catalogue Number: PS2682GTIN: 05055273204896Catalogue Number: PS2683GTIN: 05055273204902Catalogue Number: PS2684GTIN: 05055273204919ARTG Number: 199684
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA