Events

Retiro De Equipo (Recall) de Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). 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 Bioline Aust 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-00167-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-02-11
  • 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-00167-1
  • 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
    A report has been received that the foil pouches for some ebv-na substrate slides appear to have been damaged, resulting in exposure to moisture and a decrease in slide reactivity/loss of fluorescence. it has also been determined that the desiccant packaged with the compromised ebv-na substrate slides have turned pink, indicating exposure to moisture. the desiccants are typically blue. internal testing has demonstrated that the positive control tested with an ebv-na substrate slide from a damaged pouch with pink desiccant shows no fluorescence, which is interpreted as an invalid reaction according to the product package insert. there is no impact to patients. this action was carried out prior to consultation with the therapeutic goods administration (tga).
  • Acción
    Bioline is advising users to check the colour of the desiccant prior to use. If the desiccant is pink, the slides should not be used. Blue desiccant pouches can be used to testing if the control results are acceptable. This action has been closed-out on 03/08/2016.

Device

Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). An in vit...
  • Modelo / Serial
    Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). An in vitro diagnostic medical device (IVD)Lot Number: EB150G160Substrate Slide Lot Number: 2921-366Expiry Date: 30 June 2016ARTG Number: 214645
  • Manufacturer
    Bioline Aust Pty Ltd

Manufacturer

Bioline Aust Pty Ltd