Events

Rappel de Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. 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-2015-RN-01017-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-10-19
  • 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-2015-RN-01017-1
  • 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 confirmed that n-acetyl cysteine (nac) used in the treatment of acetaminophen overdose may cause assay interference when administered in therapeutic concentrations with assays using the trinder chemical pathways; enzymatic creatinine (cr-e) and uric acid (uric). nac interference may lead to falsely low results for uric acid and creatinine in patients who are concurrently being treated for acetaminophen overdose with nac.
  • Action
    Beckman Coulter is amending the INTERFERENCES section of the Chemistry Information Sheets to include N-Actel Cysteine. There is no requirement to review previously generated results. This action has been closed-out on 04/03/2016.

Device

Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. An in vitro diagnosti...
  • Modèle / numéro de série
    Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. An in vitro diagnostic medical device (IVD)Product Codes: A60298 (CR-E), All Lot Numbers are affectedARTG Numbers: 213984 and 222819
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd