Events

Retiro De Equipo (Recall) de Coxiella burnetii IFA IgG Kit

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-01149-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-08
  • 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-2016-RN-01149-1
  • 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
    Some coxiella burnetii ifa igg slides in kits from lot number 15c403 are labelled “leishmania infantum” instead of “coxiella burnetii”. the affected slides, while showing the inscription leishmania infantum, are coated with coxiella burnetii antigen and have the same features and performance as the slides labelled correctly with the coxiella burnetii inscription. of the slides checked by vircell, only 0.3% present with this labelling anomaly.
  • Acción
    Abacus ALS is advising users to cease use of stock with the affected lot number. Abacus will replace affected stock with unaffected stock. A look back of previous results is at the discretion of the laboratory director. This action has been closed out on 13 Jun 2017.

Device

Coxiella burnetii IFA IgG Kit
  • Modelo / Serial
    Coxiella burnetii IFA IgG KitReference Number: PCOBUGKit Lot Number: 15C304Slide Lot Number: 15C403ARTG Number: 212957An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd