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-00817-1
  • 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-00817-1
  • 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
    The manufacturer merck-millipore has advised seqirus of an issue with anti-m monoclonal blood grouping reagents producing weak or negative testing results when testing m+ red blood cells in line with the method described in the instructions for use (ifu). seqirus sources these reagents as raw material items, which are then subject to acceptance testing and labelling / packaging and then distributed as seqirus epiclone anti-m. as part of batch release these materials passed all potency and specificity requirements, and there have not been any product technical complaints or market feedback of testing issues regarding these products.
  • Action
    Seqirus is advising users to quarantine all affected stock from inventory. Seqirus will arrange collection of affected stock from customers.

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: 00980501Pack Size: 1 unit per packLot Numbers: 009817001, 009817101 (exp 10/11/17), 009817201 (exp 11/11/17), 009817301, 009817401 (exp 09/12/19) and 009817501 (exp 05/12/19)ARTG: 225013
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd