Events

Rappel de ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing.

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-00470-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-08
  • 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-00470-1
  • 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
    A biomérieux investigation has confirmed a potential performance issue on strain categorization for streptococcus viridans group and streptococcus pneumoniae based on 2017 clsi and eucast breakpoints, which could lead to false susceptible result instead of resistant results on etest etp32 blister packaging when comparing to the broth-micro dilution (bmd) reference method.
  • Action
    bioMérieux is advising customers who use the 2017 CLSI and 2017 EUCAST clinical guidelines that they can continue the use of ETEST ETP32 blister packaging except for Streptococci group including S. pneumoniae strains. bioMérieux is also advising that laboratories should identify any possible false Susceptible results from previously performed tests and analyse the related risks and determine appropriate actions if relevant.

Device

ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial sus...
  • Modèle / numéro de série
    ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing.Reference Number: 531600 Multiple Lot NumbersARTG Number:187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd