Events

Retiro De Equipo (Recall) de Asserachrom Von Willebrand Factor (VWF):Collagen (CB). 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 Diagnostica Stago 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-00588-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-10
  • 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-00588-1
  • 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
    Following a customer complaint, stago has investigated and confirmed that asserachrom vwf:cb lot 114710(re) gives higher results compared to the other asserachrom vwf:cb tested lots for samples with a vwf:cb level above 30%. this issue is more pronounced for samples with a vwf:cb level above 50%.Based on internal testing by stago, normal samples tested are overestimated by 26% on average (relative deviation). for example: a normal plasma at 134% could be reported at 167%.The pathology samples tested and in particular the type 1 plasmas are overestimated by 38% on average (relative deviation). for example: a type 1 plasma at 56% could be reported at 75%.The quality control (qc) included in the kit does not always detect the issue.
  • Acción
    Diagnostica Stago is advising users to stop using and destroy the affected lot according to current local regulations. Replacement kits will be provided.

Device

Asserachrom Von Willebrand Factor (VWF):Collagen (CB). An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Asserachrom Von Willebrand Factor (VWF):Collagen (CB). An in vitro diagnostic medical device (IVD). Reference Number: 00239Lot Number: 114710(RE)ARTG Number: 185170
  • Manufacturer
    Diagnostica Stago Pty Ltd

Manufacturer

Diagnostica Stago Pty Ltd