Events

Rappel de Cortisol Saliva ELISA. 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-2018-RN-00109-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-07
  • 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-00109-1
  • 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
    The manufacturer, ibl has detected an issue that indicates a degradation in performance of the kit resulting in elevated cortisol values. when testing patient samples with one of the affected lots, the controls and calibrator values will meet specifications; however, due to a degradation in the starting concentration of the calibration standards, the calculated results for individual patient samples may be higher compared to lc-ms/ms measurements and may trigger unnecessary additional testing.A review of additional data comparing the respective kit standards of the lots to lc-ms/ms data it is evident that the lots eco142 to eco143 generate elevated results:- eco142 (passing bablok fit (y=0.009988 + 1.549x)- eco143 (passing bablok fit (y=0.003142 + 1.623x)there has not been any reports of injuries associated with this issue.
  • Action
    Abacus is advising users to inspect stock and quarantine any remaining stock of the affected batches. Affected product will be replaced with unaffected stock. A review of previously generated patient results is at the discretion of the Laboratory Director.

Device

Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)Catalogue Number: RE52611Lot Numbers: ECO142, ECO143Expiry Dates: ECO142: 2018-02-28; ECO143: 2018-12-31ARTG Number: 210636 (Abacus ALS - Clinical chemistry hormone IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd