Events

Rappel de Access AMH QC Kits for use with Access Family of Immunoassay Systems. 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 Beckman Coulter Australia 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-2016-RN-00859-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-06-29
  • 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-2016-RN-00859-1
  • 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
    Beckman coulter has identified that the quality control (qc) value card includes incorrect standard deviation values for the access amh qc kit, lot 689202. the qc value card for this lot lists the following standard deviation values: qc1 as 0.02, qc2 as 0.11 and qc3 as 0.65. the correct standard deviation values are as follows: qc1 is 0.15, qc2 is 0.76 and qc3 is 2.30. use of this restrictive qc range may result in qc failures but there is no impact to patient results.
  • Action
    Beckman Coulter is advising users to use the correct QC values, as provided, when establishing QC ranges for the affected lot. Users should also confirm that the Access AMH QC assigned mean and standard deviation values are set appropriately per individual laboratory procedures. This action has been closed-out on 20/02/2017.

Device

Access AMH QC Kits for use with Access Family of Immunoassay Systems. An in vitro diagnostic medi...
  • Modèle / numéro de série
    Access AMH QC Kits for use with Access Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD).Reference Number: B13129Lot Number: 689202Expiry date: 16 September 2017ARTG Number: 213976
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd