Events

Rappel de Trinity Biotech Captia Cytomegalovirus (CMV) IgG

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 Trinity Biotech.

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
    15374
  • Date de mise en oeuvre de l'événement
    2013-09-16
  • 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: Banksia Scientific Pty Ltd (NZ), 12 Brigade Street, Airport Oaks, Auckland
  • Cause
    Upon review of the qa release testing, the range that was calculated at the time of kit release was calculated per standard operating procedures and supports the positive control range that was assigned upon release of 2.2-4.1., however, upon investigation of history (as a positive control in several kit lots) and additional testing it has been re-evaluated and determined that this range requires an adjustment to 2.2-4.6., if you have used this kit lot to test and report patient results, and the positive control was within the assigned range (2.2-4.1), then the reported patient results were valid.
  • Action
    Instructions for use to be updated

Device

Trinity Biotech Captia Cytomegalovirus (CMV) IgG
  • Modèle / numéro de série
    Model: Product Code: 2325200, Affected: Lot Number: 557
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech