Events

Rappel de VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. 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-01333-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-06
  • 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-01333-1
  • 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 customer reports indicating occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc 700327 in association with specific vitek 2 gp id lots, causing failure of the quality control (qc) testing for the vitek 2 gp id card. the expected o129r reaction for atcc 700327 strain is positive.An internal investigation determined that a positive dsor reaction that occurs early in the incubation of the card is causing an earlier end to the analysis of the card leading to an atypical negative reaction for o129r.
  • Action
    bioMérieux is advising users to review inventory and discard any remaining stocks of the affected lots. A review of previously generated results is at the discretion of the Laboratory Manager.

Device

VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VITEK 2 Gram-Positive (GP) Identification (ID) Test Kit. An in vitro diagnostic medical device (IVD)Batch/Lot Number: 2420192403Expiry: 06 June 2018Batch/Lot Number: 2420198203Expiry: 12 June 2018ARTG Number: 215320
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd