Events

Retiro De Equipo (Recall) de VIDAS Anti HBs Total II. 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 Biomerieux 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-01002-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-09-16
  • 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-01002-1
  • 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 information referenced in the current ifu is incorrect with regards to specimen stability for samples in stoppered tubes. in the instruction for use (ifu), the paragraph “specimen stability” states, “the stability of the sample separated from the clot has been validated using samples in stoppered tubes: at 18-25°c for 3 days”. further review identified that the data of the stability study mentioned in the product review development report file (ref. vr11) is “for stoppered tubes, at 18-25°c for 8 hours”. the instructions for use should state: “the stability of the sample separated from the clot has been validated using samples in stoppered tubes at 18-25°c for 8 hours”.
  • Acción
    BioMerieux is notifying their customers that the IFU incorrectly states that sample is stable for 3 days at 18-25 degrees C once separated from the clot. The correct stability is 18-25 degrees C for 8 hours. This action has been closed-out on 01/03/2016.

Device

VIDAS Anti HBs Total II. An in vitro Diagnostic Medical Device (IVD)
  • Modelo / Serial
    VIDAS Anti HBs Total II. An in vitro Diagnostic Medical Device (IVD)Reference Number: 30318Lot Number: 1002903980
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd