Events

Rappel de BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria including mycobacterium tuberculosis)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Becton Dickinson 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-2013-RN-00975-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-17
  • 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-2013-RN-00975-1
  • 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
    Bd has determined that affected bbl mgit tubes were labelled with an incorrect barcode, such that the correct barcode prefix "43 01" was actually printed as "43 02". the manufacturer identified this error prior to supplying the product and over labelled the product with the correct barcode. the manufacturer has identified that the over labels may peel off in varying degrees which exposes the incorrect barcode. this can result in mgit false negative results.
  • Action
    BD is requesting users to discontinue use and discard any remaining inventory of the affected product. Replacement stock will be provided by BD. The package insert recommends that users perform a visual check of all instrument negative tubes. Tubes that appear to be positive should be sub-cultured, acid-fast stained and treated as a presumptive positive. A review of previously reported results is not required if this protocol is followed.

Device

BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria i...
  • Modèle / numéro de série
    BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria including mycobacterium tuberculosis)Catalogue Number: 245122Lot Number: 3061013Expiry date: 6 September 2014An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd