Events

Rappel de BioCSL Phenocell C Reagent, 3%

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 Seqirus Pty Ltd.

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
    14917
  • Date de mise en oeuvre de l'événement
    2013-07-01
  • 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: Seqirus Pty Ltd, 63 Poplar Road, Parkville, VIC 3052, AUSTRALIA
  • Cause
    The antigen composition sheet supplied with the product listed cell 5 as lua negative. however, a customer complaint was received from the imvs adelaide red cell reference laboratory that they typed cell 5 as lua positive. confirmatory testing performed by biocsl in response to the customer complaint has confirmed that cell 5 did in fact type as lua positive.
  • Action
    Manufacturer to issue advice regarding use

Device

BioCSL Phenocell C Reagent, 3%
  • Modèle / numéro de série
    Model: Catalogue Number: 86640201, Affected: Lots: 8664052, 8664053, 8664054
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd