Events

Rappel de Haemophilus Test medium (HTM). 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 Biomerieux Australia 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-00831-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-03
  • 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-00831-1
  • 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
    Biomérieux have received reports regarding an issue with the use of the 04054 haemophilus test medium. (lot number hdk-206). the issue is related to the media not supporting the growth of haemophilus influenza isolates (atcc 49766 and atcc 49247).
  • Action
    bioMérieux is requesting Customers cease using lot number HDK-206 (04054 Haemophilus Test medium). It is also recommended that results which have an ongoing clinical impact be re- examined using a different lot number of 04054 Haemophilus Test medium. Distribute this information to all appropriate personnel in your laboratory including others to whom you may have transferred the product, retain a copy in your files. 2. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. 3. Quarantine inventory of 04054 Haemophilus Test medium (HTM) for Lot # HDK-206 and discard all affected products in an appropriate manner. Please complete and return the acknowledgement form to qa.anz@biomerieux.com to confirm receipt and credit.

Device

Haemophilus Test medium (HTM). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Haemophilus Test medium (HTM). An in vitro diagnostic medical device (IVD)Product Number: 04054Lot Number: HDK-206ARTG Number: 201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd