Events

Rappel de ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD). LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, and DiaClon Type + Screen

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-00318-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-20
  • 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-00318-1
  • 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 laboratories have been able to confirm an increased level of antibody of undetermined specificity (aus) when using some reagents of the id-system intended for irregular antibody screening and identification.
  • Action
    BioRad is advising that the capacity of impacted lots of ID-Cards to detect and identify clinically significant antibodies is not affected by this issue. For that reason users may continue to use these products for their intended purpose. In the event users experience an AUS level impacting the ability to render final results, users should consider using an alternative method such as the tube method to verify results.

Device

ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro d...
  • Modèle / numéro de série
    ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD). LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, and DiaClon Type + ScreenProduct ID Numbers: 50531, 50540, 50571, 50581,50682Multiple Catalogue and Lot NumbersARTG Number: 212527(Bio-Rad Laboratories - Multiple blood grouping and typing IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd