Events

Rappel de DiaClon ABO/D+ Reverse Grouping for Patients. 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-2018-RN-00321-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-04-24
  • 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-00321-1
  • 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 have been made aware that a limited amount of id-cards diaclon abo/d + reverse grouping for patients, lot 50093 87 17, were packed in boxes stating a storage temperature range of 2-8°c on the outer carton instead of 18-25°c for this product.The product label shows the correct storage conditions for this product. this issue has no impact on product used prior to may 1 2018.
  • Action
    Bio-Rad is advising users to inspect their inventory to confirm that the affected lot has been stored between 18-25°C and not 2-8°C. If for any reason the product is stored at 2-8°C, please discard product after 1st May 2018.

Device

DiaClon ABO/D+ Reverse Grouping for Patients. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    DiaClon ABO/D+ Reverse Grouping for Patients. An in vitro diagnostic medical device (IVD).Catalogue Number: 001267Displayed Lot Number: 50093 87 17SAP Lot Number: 2201808717Expiry Date: 31/01/2019ARTG Number: 212527
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd