Events

Rappel de Etest PIPTAZO PTC 256 (used for testing of Enterobacteria strains). 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-2015-RN-01171-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-12-02
  • 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-2015-RN-01171-1
  • 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
    It has been identified that isolates (enterobacteria strains) were tested with agar dilution and broth micro dilution reference method:using eucast breakpoints (mic< or =8: susceptible ; mic>16: resistant), etest pip/tazo showed a higher frequency of erroneous results, false susceptible results, when comparing to the referenced method (broth-micro dilution).The risk to patients as a result of the performance shift is the potential for reporting erroneous results for piperacillin/tazobactam; specifically false susceptible results. this risk may lead to medical intervention for the patient because the erroneous result could negatively influence the selection of antibiotic therapy.
  • Action
    Biomerieux is advising users to discontinue use and discard any remaining units. Biomerieux is advising users to discuss any concerns regarding previously reported results with the Laboratory Medical Director. This action has been closed-out on 31/08/2016.

Device

Etest PIPTAZO PTC 256 (used for testing of Enterobacteria strains). An in vitro diagnostic medica...
  • Modèle / numéro de série
    Etest PIPTAZO PTC 256 (used for testing of Enterobacteria strains). An in vitro diagnostic medical device (IVD) Catalogue Number: 412434, 521418 Multiple Lot Numbers affectedARTG Number: 187139
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd