Events

Rappel de chromID S.aureus agar (SAID/MRSA). 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-00804-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-26
  • 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-00804-1
  • 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
    During an internal investigation, biomérieux observed an anomaly on nine (9) lots of chromid s. aureus manufactured with the same semi-finished lot.This anomaly is causing a delayed colouration of the colonies which appear white/light green instead of green resulting in a potential false negative result. biochemical and/or immunological tests must be performed to identify colonies other than green ones (white, pink or mauve): therefore, the risk of delivering a false negative result is mitigated if the instructions for use have been followed.
  • Action
    Biomerieux is advising users to discontinue use and discard any remaining inventory of the affected product. Biomerieux advises that users should discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 18/08/2016.

Device

chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)chromID S.aureus agar (SAID)Lot Numbers: 1004119200, 1004044190, 1004085400chromID MRSA agar / chromID S. aureus agar (MRSA/SAID)Lot Numbers: 1004158090, 1004091980, 1004113000, 1004141170ARTG Number: 182081An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd