Events

Rappel de Horse Blood Agar. 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-2018-RN-00353-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-05-02
  • 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-2018-RN-00353-1
  • 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 has identified an issue at their brisbane culture media manufacturing site regarding product reference number 04059, lot number jcu-203, horse blood agar. during post release testing a potential contamination issue (contaminated deep and surface) has been identified. the microorganism was identified as a gram positive bacilli.
  • Action
    bioMérieux is requesting that Laboratories should: 1.Stop using HBA ref. 04059, Lot JCU-203 and segregate the product and discard/dispose appropriately under the relevant laboratory guidelines; 2.Complete and return Attachment A from the customer letter to qa.anz@biomerieux.com in order to confirm receipt; and 3.Contact your local bioMérieux representative for product compensation as necessary.

Device

Horse Blood Agar. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Horse Blood Agar. An in vitro diagnostic medical device (IVD)Reference Number: 04059Lot Number: JCU-203ARTG Number: :201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd