Events

Rappel de Roche PreciControl ClinChem Multi 2

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
    19212
  • Date de mise en oeuvre de l'événement
    2015-10-13
  • 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 has received a number of complaints that the recovery of c-reactive protein gen. 3 (crpl3) was too high in precicontrol clinchem multi 1 (pccc1), and especially in precicontrol clinchem multi 2 (pccc2), seen mainly on the cobas c 501 module., roche diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. to resolve this issue a revised target value assignment procedure was necessary., target values for currently available pccc1 and pccc2 control lots have been adjusted as per the tables given in the customer letter.
  • Action
    Instructions for use to be updated

Device

Roche PreciControl ClinChem Multi 2

Manufacturer

Roche Diagnostics GmbH