Events

Rappel de MRSASelect II agar. 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 Bio-Rad Laboratories 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-00703-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-14
  • 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-00703-1
  • 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
    Bio-rad have identified that certain lots of mrsaselect ii agar may have abnormal colouration and growth of non-characteristic mrsa colonies.If plates were exposed to light but none defects have been detected before use, then mrsa colonies may appear white to yellow instead of the pink characteristic colour, or the growth may be delayed. as a result, there is a risk of misinterpretation of the result.
  • Action
    Bio-Rad is advising: - For the references and batches of affected product, do not expose the boxes more than 4 hours to light during the intermediate storage steps, including returning at room temperature, and during incubation until the reading step. - Do not use a suspicious colour agar. - As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or Pastorex Staph Plus.

Device

MRSASelect II agar. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    MRSASelect II agar. An in vitro diagnostic medical device (IVD).Catalogue Numbers: 63757 & 63759Multiple Lot NumbersARTG Number. 188609(Bio-Rad Laboratories - Microbiological culture media IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd