Events

Rappel de Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). 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 Abacus ALS 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-2017-RN-00063-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-12
  • 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-2017-RN-00063-1
  • 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
    Some lots of the crag lfa have been found to have reduced specificity (90% now versus 99% before). the health risk only applies to patients with positive test results. a small number of samples with positive test results may not be true positives, which may cause some patients to initiate unnecessary anti-fungal therapy. samples with negative test results are not affected. the negative predictive value remains high at nearly 100%. there have been two customer complaints associated with this problem. there have been no reports of patient injury or death.
  • Action
    Abacus ALS is advising users to destroy stock from the affected lots to prevent further use. Replacement stock will be provided. Customers may decide to retest samples previously reported as positive using affected lots. Abacus ALS will provide replacement tests to perform retesting if this is required. This action has been closed-out on 01/03/2018.

Device

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).Kit Item Number: CR2003Lot Numbers: 161019161504NZ & 161007110553JGARTG Number: 272537
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd