Events

Rappel de Biomerieux FB Reagent

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 Biomerieux SA.

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
    16417
  • Date de mise en oeuvre de l'événement
    2014-03-27
  • 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: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Cause
    During the quality control of new lot of fb reagent, a visual defect (colour issue) was observed. the first investigation performed by the manufacturing site showed that this visual defect is due to a specific lot of raw material used for the manufacturing of this fb reagent. in addition, this lot of raw material has also been used for the manufacturing of several lots of fb reagent and zym b reagent using the same raw material than the fb reagent. as the involved lots of zym b reagent are included inside of api nh and api listeria kits, the both references are also impacted.
  • Action
    Instructions for use to be updated

Device

Biomerieux FB Reagent
  • Modèle / numéro de série
    Model: Reference: 70562, Affected: All lots
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA