Events

Rappel de Roche AFB III Staining Kit

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par manufacturer #1479.

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
    17624
  • Date de mise en oeuvre de l'événement
    2014-11-07
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 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 should recognise the artefacts and reject the slide without attempting to interpret it.
  • Action
    Product to be destroyed

Device

Roche AFB III Staining Kit
  • Modèle / numéro de série
    Model: , Affected: Lot Numbers: D05755, D11015, E1024 and E03378
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479