Events

Rappel de Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia 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
    RC-2017-RN-01361-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-17
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01361-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Seqirus has received notification that epiclone anti m lot 009817601 is showing false positive m reactions with m negative control cells in cat (column agglutination technology) biovue cards. investigational testing by seqirus suggests that there is an incompatibility between anti-m lot 009817601 and the cat biovue cards.
  • Action
    Seqirus is advising customers to only use the product for phenotyping via the Tube method. Users should not continue use of the product with Column Agglutination Technology (CAT) Cards. Seqirus is advising laboratories to perform a review of previous positive reactions obtained where CAT Cards have been used with Epiclone Anti M Lot 00981760.

Device

Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)Product Item Number: 00980501Expiry: 11/06/2019Pack Size: 1 unit per packLot Number: 009817601ARTG: 225013 (Immunohaematology blood grouping
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd