Events

Rappel de ETEST Teicoplanin 256 (TP) SPB and Foam packaging. 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-01530-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-19
  • 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-01530-1
  • 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
    Following an assessment of etest teicoplanin with staphylococcus spp., biomerieux observed an underestimation of mic values by at least 1 dilution for coagulase negative staphylococci (cons); even though the mic essential agreement at +/- 1 dilution is > 95% between etest tp256 and the reference method agar dilution (ad) for staphylococcus spp.This underestimation leads to a risk of false susceptible results linked, in particular to the lack of an intermediate category interpretation if eucast breakpoints are applied for this antibiotic. during the study, the false susceptible rate observed was 37.5% for cons, where strains with an mic at 8 mg/l, by the reference method (resistant) can be found susceptible by etest teicoplanin.
  • Action
    biomerieux is advising users to stop using ETEST Teicoplanin for testing of CoNS and use an alternative method. The test can continue to be used with other microorganisms. For tests previously performed, users are advised to identify any possible false susceptible results that may have occurred, to analyse the related risks and to determine appropriate actions, if relevant.

Device

ETEST Teicoplanin 256 (TP) SPB and Foam packaging. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ETEST Teicoplanin 256 (TP) SPB and Foam packaging. An in vitro diagnostic medical device (IVD)Reference Number: 412461 & 522018Multiple serial numbers affectedARTG Number: 187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd