Events

Rappel de Sensitest Agar

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-2016-RN-01142-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-02
  • 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-2016-RN-01142-1
  • 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 biomérieux 04134 sensitest agar. the issue is related to the testing of cefoxitin 10µg disc on staphylococcus aureus yielding zones of inhibition of 5.5 to 6.5 annular radius with isolates of methicillin-resistant staphylococcus aureus (mrsa) (confirmed meca positive). in addition, there are also problems with the lawn growth of staphylococcus intermedius which impacts adversely on susceptibility testing of that organism. the size (<8mm) and morphology of the zone should immediately raise suspicion however, the isolates could be reported as susceptible to cefoxitin (methicillin). therefore, there is the potential for underdiagnoses of mrsa.
  • Action
    As a precautionary measure, BioMérieux is strongly recommending that, as an interim measure while investigations are continuing, to cease using 04134 Sensitest Agar for Staphylococcus sp. and test staphylococci on 04091 Mueller Hinton Agar. It is also recommended that recent results be re-examined using 04091 Mueller Hinton Agar and/or perform MecA testing. Discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. BioMérieux is continuing to investigate the issue in consultation with the Therapeutic Goods Administration (TGA). Further correspondence may be provided following the outcome of the investigations.

Device

Sensitest Agar
  • Modèle / numéro de série
    Sensitest AgarProduct Code: 04134All lot numbers affectedARTG Number: 201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd