Events

Rappel de ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)

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-2018-RN-00090-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-01-30
  • 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-2018-RN-00090-1
  • 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 a study conducted on etest polymyxin b with 180 clinical strains (pseudomonas aeruginosa, acinetobacter and enterobacteriaceae), an underestimation of mics has been observed for pseudomonas aeruginosa and acinetobacter species, compared to those obtained using the broth micro-dilution (bmd) reference method. this has led to false susceptible results when the etest polymyxin b results are interpreted using clsi breakpoints; there are no breakpoints for this drug in the eucast guidelines. as a consequence, etest polymyxin b (ref. 533400 & 533408) blister packaging can no longer be recommended for use with pseudomonas aeruginosa or acinetobacter strains.
  • Action
    bioMérieux is advising customers to discontinue use of the ETEST Polymyxin B strips to determine the MICs for Pseudomonas aeruginosa or Acinetobacter species. Laboratories can continue to use ETEST Polymyxin B for Enterobacteriaceae species.

Device

ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)
  • Modèle / numéro de série
    ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)POLYMYXIN B PO 1024 WW B30 Reference Number: 533400Batch Numbers: 1005807890, 100575830, 1005497750, 1005161530, 1004414690POLYMYXIN B PO 1024 WW B100Reference Number: 533408Batch Number: 1004530070ARTG Number: 187139 (Biomerieux Australia Pty Ltd - Antimicrobial susceptibility testing IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd