Events

Rappel de Access BR Monitor used with the 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-2017-RN-01360-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-25
  • 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-01360-1
  • 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
    In april 2017 (tga reference rc-2017-rn-00500-1) beckman coulter advised customers of issues with the access br monitor relating to results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu).As a follow up, beckman coulter will update the access br monitor instructions for use (ifu). the updated ifu will reflect the 95th percentile upper reference limit (url) value for a healthy population, which was determined to be 23.5 u/ml. there is no change to the access br monitor assay.
  • Action
    Beckman Coulter is advising users of the updated 95th percentile upper reference limit (URL) value for a healthy population, which is 23.5 U/mL. Beckman Coulter is recommending that users review the contents of this letter with the Laboratory Medical Director. This URL change may mean that some patient test results should be reassessed depending upon how the URL is established by the laboratory.

Device

Access BR Monitor used with the Access family of Immunoassay systems. An in vitro diagnostic medi...
  • Modèle / numéro de série
    Access BR Monitor used with the Access family of Immunoassay systems. An in vitro diagnostic medical device (IVD)Reference Number: 387620Lot Numbers:623913 (exp 31 May 2017)625701 (exp 30 Aug 2017)628771 (exp 30 Sep 2017)630349 (exp 31 Jan 2018)633070 (exp 28 Feb 2018)723522 (exp 31 Mar 2018)723523 (exp 30 Apr 2018)723741 (exp 30 Jun 2018)723916 (exp 31 Jul 2018)All future lotsARTG Number: 213975
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd