Events

Rappel de ID-Papain Assay. 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-2016-RN-00492-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-29
  • 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-00492-1
  • 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
    Following customer complaints, bio-rad has been able to confirm that the affected lots show a decrease in enzymatic activity, leading to false negative or false positive results. bio-rad is recalling the lots identified. this recall is being conducted as a precautionary measure.A risk assessment has been carried out and revealed that difficulty in interpretation of the results involving identification, auto-control and cross-matching in the enzyme technique may be experienced which may result in a delay in transfusion.
  • Action
    Bio-Rad is advising customers to destroy remaining units of the affected lots, and is recommending using ID-Diluent as an alternative. This action has been closed-out on 03/02/2017.

Device

ID-Papain Assay. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ID-Papain Assay. An in vitro diagnostic medical device (IVD)Catalogue Number: 005510Lot Numbers: 06311.53.1 (Expiry date 25/04/2016)06311.54.1 (Expiry date 09/05/2016)06311.55.1 (Expiry date 23/05/2016)ARTG Number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd