Events

Rappel de Sorenson’s Buffer. 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 Thermo Fisher Scientific 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-2016-RN-00884-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-07-07
  • 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-2016-RN-00884-1
  • 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
    There are three deficiencies in the current labelling of sorenson’s buffer (ph 6.8 and 7.2). the labels are: 1) missing the dilution instructions, 2) have the incorrect spelling of sorenson’s and 3) do not clearly describe the product as concentrated. thermo fisher scientific has confirmed that the product, apart from the labelling, has not changed in any way. in the event of the product being used undiluted, there is minimal ph variation between the concentrated and diluted solutions (0.2 units) and consequently, no to minimal risk on performance. the corrected label has been applied to all stock on hand at thermo fisher scientific to include the concentration and dilution instructions.The corrected label has been applied to all stock on hand at thermo fisher scientific to include the concentration and dilution instructions.
  • Action
    Thermo Fisher Scientific is providing users with the correct labels and advising that the correct dilution factor is 1 in 10 diluted with deionised water.

Device

Sorenson’s Buffer. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Sorenson’s Buffer. An in vitro diagnostic medical device (IVD)Product Codes: FNNGG029 and FNNGG030Affected Lot Numbers: 1603216780, 1506195360, 1508200130, 1509202540, 1509203020 and 1510206300ARTG Number: 244172
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd