Events

Rappel de Gentian Cystatin C Calibrator Kit. 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-2017-RN-00992-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-07
  • 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-2017-RN-00992-1
  • 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 gentian has identified an issue with two specific lots of gentian cystatin c calibrator kit (lot 0006 and 0008). the identified lots of calibrators resulted in a high bias when used on a dxc instrument. potential risks associated with the increased bias are an underestimation of the cystatin c value, which again gives an overestimation of gfr. the bias should be detected when using controls for validation of the calibration curve. as a worst case in the event this is not detected by the controls, the bias may be close to 20%.
  • Action
    Beckman Coulter is requesting users: 1. Inspect their stocks and immediately stop using calibrator lots 0006 and 0008; 2. Share this information with laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, provide them a copy of this letter; 3. Complete and return the Response Form supplied with the Customer Letter within 10 days as confirmation of receipt of this important communication; and 4. If you have any questions regarding this notice, contact your local Beckman Coulter Representative.

Device

Gentian Cystatin C Calibrator Kit. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Gentian Cystatin C Calibrator Kit. An in vitro diagnostic medical device (IVD)Part number: A52763Kit Lot Numbers: 0006 and 0008ARTG Number: 261302
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd