Events

Rappel de ID-LISS/Coombs Cards. 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-2015-RN-00314-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-13
  • 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-2015-RN-00314-1
  • 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
    Unexpected reactions may rise in the 6th well of lot 50531.95.14 (exp. date 30/06/2016) product id: id-liss coombs cards reference 004017v (24 x 12 id-cards). investigations have identified that a high level of 'broken gel' during a certain time period during filling and only a very limited quantity of id-cards are affected by this phenomenon of unexpected reaction in the 6th well.
  • Action
    To limit unexpected reactions, customers are asked to stop using the affected boxes (number between 5-1156-288 and 5-1156-318) and to destroy the remaining stock locally. Replacement unaffected stock will be sent.

Device

ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)Ref: 004017VLot Number: 50531.95.14 (Exp 30.06.2016)Affected Box numbers: 5-1156-288 to 5-1156-318ARTG number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd