Events

Rappel de Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). 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 Bioline Aust 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-00167-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-02-11
  • 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-00167-1
  • 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
    A report has been received that the foil pouches for some ebv-na substrate slides appear to have been damaged, resulting in exposure to moisture and a decrease in slide reactivity/loss of fluorescence. it has also been determined that the desiccant packaged with the compromised ebv-na substrate slides have turned pink, indicating exposure to moisture. the desiccants are typically blue. internal testing has demonstrated that the positive control tested with an ebv-na substrate slide from a damaged pouch with pink desiccant shows no fluorescence, which is interpreted as an invalid reaction according to the product package insert. there is no impact to patients. this action was carried out prior to consultation with the therapeutic goods administration (tga).
  • Action
    Bioline is advising users to check the colour of the desiccant prior to use. If the desiccant is pink, the slides should not be used. Blue desiccant pouches can be used to testing if the control results are acceptable. This action has been closed-out on 03/08/2016.

Device

Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). An in vit...
  • Modèle / numéro de série
    Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). An in vitro diagnostic medical device (IVD)Lot Number: EB150G160Substrate Slide Lot Number: 2921-366Expiry Date: 30 June 2016ARTG Number: 214645
  • Manufacturer
    Bioline Aust Pty Ltd

Manufacturer

Bioline Aust Pty Ltd