Events

Rappel de ID-DiaCell l-ll-lll ID-DiaPanel

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 Bio-Rad Laboratories 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
    21117
  • Date de mise en oeuvre de l'événement
    2017-02-28
  • 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: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Cause
    The manufacturer has become aware of unexpected reactions primarily on eluates and qc samples but also with some patient samples when using the id-diacell l-ll-lll and id-diapanel products. in case of doubtful reactions, please re-test with a new kit. if the results remain in doubt, the manufacturer advises to send the sample to a reference laboratory and if an urgent transfusion is required, perform a crossmatch., follow up 24 feb 2017: there has been further development (follow up) from our manufacturer additional 3 other devices that are also affected., the manufacturer received complaints regarding indirect antiglobulin test (iat), especially when eluates and qc samples were tested, less frequently when patient samples were tested.
  • Action
    Manufacturer to issue advice regarding use

Device

ID-DiaCell l-ll-lll ID-DiaPanel

Manufacturer

Bio-Rad Laboratories Inc