Events

Rappel de AQUIOS CL Flow Cytometry System

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 Beckman Coulter Inc.

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
    22097
  • Date de mise en oeuvre de l'événement
    2017-12-05
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Cause
    The manufacturer is advising that when aquios cl systems are connected to a laboratory information system (lis), the system may duplicate sample requests leading to sample mis-identification., this is an updated notification in follow-up to the previous communication received (dated 16 october 2017) concerning duplicate sample requests leading to sample mis-identification when using the aquios cl systems connected to a laboratory information system (lis). this important information needs immediate attention. the information replaces the instructions in the original notification dated 16 october 2017.
  • Action
    Manufacturer to issue advice regarding use

Device

AQUIOS CL Flow Cytometry System
  • Modèle / numéro de série
    Model: , Affected: software versions (2.0, 2.0.1 and 2.1)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc