Events

Rappel de API ZYM B. 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-01270-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-24
  • 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-01270-1
  • 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
    Based on discrepant results (false negative results) reported from the field, biomérieux initiated a complaint investigation to confirm product performance and determine root cause. the investigation confirmed a loss of performance after 3 months of shelf life for api zym b, which led to false negative results on some api strips using the zym b reagent. as a result of the zym b performance shift, the risk is to potentially report a false negative result of some api tests; misidentification of some species with api 20 strep, api nh, api listeria and api coryne. api staph is not impacted by a risk of misidentification. regarding api zym, as it is designed for the research of enzymatic activities, there is no risk of microorganism misidentification.
  • Action
    Biomerieux is advising users to perform quality control with ATCC strains prior to using the ZYM B ampule. A review of previously reported results is recommended at the discretion of the Laboratory Director.

Device

API ZYM B. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    API ZYM B. An in vitro diagnostic medical device (IVD)Product Code: 70493Multiple Lot numbers affectedARTG Number: 232822
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd