Events

Rappel de Sysmex

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 Roche Diagnostics GmbH.

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
    21687
  • Date de mise en oeuvre de l'événement
    2017-07-14
  • 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
    It has been reported that a possible mix up of results could occur during 'user modification' of a barcode misread in the following circumstances:, 1. di-60 encountered a problem reading the barcode when processing a slide (slide 1) and a picture of the barcode for slide 1 is taken by the di-60., 2. when this occurs the di-60 provides slide 1 with a temporary order id based on the date and time (ie erryyyymmddhhmmss) and the image of the barcode picture (taken in step 1) is stored in the database and displayed in the order data dialogue against this err id., 3. following this, a slide (slide 2) from the slide maker/stainer (sp-10) which has had a barcode misread occurring on the sp-10 and has been.
  • Action
    Manufacturer to issue advice regarding use

Device

Sysmex

Manufacturer

Roche Diagnostics GmbH