Events

Rappel de Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. 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 bioCSL 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-01146-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-11-24
  • 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-2015-RN-01146-1
  • 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
    This product is a 3 cell screening panel that is used in immunohematology testing to screen patient plasma or serum samples for the presence of clinically relevant red cell alloantibodies for pre transfusion and pre-natal testing.Cell 2 when tested against weak anti e controls (i.E. securacell) during pre-acceptance testing in biovue and grifols cat platforms, is giving weak or negative reactions and not the expected mid-strength reactions. however, testing in the bio-rad (diamed) cat platform is giving the expected result.There is a potential risk that undetected weak anti-e antibody using certain cat platforms could lead to delayed hemolytic transfusion reactions (dhtr) for the patient.
  • Action
    The sponsor Seqirus is advising the users to inspect stock and quarantine all affected units prior to their return. The sponsor will arrange the replacement of the affected units or return credit. This action has been closed-out on 29/08/2016.

Device

Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD)Abtectcell III% 0.8%Item Number: 22450201Lot Number: 2245204Expiry Date: 26/12/2015Abtectcell III% 0.8% Bulk PackItem Number: 22450205Lot Number: 2245204AExpiry Date: 26/12/2015ARTG Number: 223867
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd