Events

Retiro De Equipo (Recall) de AFB III Staining Kit (An in vitro diagnostic medical device (IVD)) (Qualitative histologic stain to selectively indicate Mycobacterium and other acid fast organisms)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿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-01161-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-29
  • 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-01161-1
  • 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
    Roche diagnostics has observed a staining artefact on slides stained with the afb iii staining kit. this artefact consists of a circular and a non-specific purple- to pink-coloured slide background staining, which in some cases is present within tissue elements and in other cases takes the form of circular deposits that appear to be above the tissue plane. the latter can occur both within the tissue-containing and blank portions of the slide. this artefact may interfere with the interpretation and identification of acid-fast bacteria, which is the indication for this assay. also, the artefact could be mistaken for acid-fast bacteria and lead to a false positive interpretation. a trained pathologist would recognise the artefacts and reject the slide without attempting to interpret it.
  • Acción
    Roche Diagnostic Australia Pty Ltd is requesting the customers to identify and discard the affected lots and is providing credit for the affected lots that are discarded. Roche Diagnostic is also requesting the customers to consider the need to review patient results using the affected lots. This action has been closed-out on 12/08/2016.

Device

AFB III Staining Kit (An in vitro diagnostic medical device (IVD)) (Qualitative histologic stain ...
  • Modelo / Serial
    AFB III Staining Kit (An in vitro diagnostic medical device (IVD)) (Qualitative histologic stain to selectively indicate Mycobacterium and other acid fast organisms) Lot Numbers: D05755, D11015, E1024 and E03378ARTG Number 174922
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited