Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Roche Diagnostics Australia Pty Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-01161-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-29
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01161-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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 ...
  • Modèle / numéro de série
    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