Events

Rappel de Roche ProCell/CleanCell Aspiration Tube Filters

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
    16654
  • Date de mise en oeuvre de l'événement
    2014-05-08
  • 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
    The manufacturer has identified that under certain conditions the white aspiration tube/filters on the end of the procell and cleancell aspiration tubes may become loose or fall off the aspiration tube completely. this in turn may allow air to enter the aspiration tube, creating foam. the liquid short sensors (lss) are unable to detect these very small bubbles. foam may be visible in the procell and cleancell reservoirs. if foam reaches the measuring cells, this may cause discrepant results. the magnitude of the discrepancy will vary with the amount of air being aspirated, particularly for procell.
  • Action
    Instructions for use to be updated

Device

Roche ProCell/CleanCell Aspiration Tube Filters
  • Modèle / numéro de série
    Model: Part number: 03149773001, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479