Events

Rappel de Trinder tests on Roche Analysers – Hitachi 902, COBAS c111, COBAS c311/501/502/701/702 & COBAS INTEGRA 400 plus/800. 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 Roche Diagnostics Australia Pty Limited.

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-00398-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-13
  • 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-00398-1
  • 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
    New interference claims for trinder tests have been verified by roche internal studies.Trinder tests measured in samples which contain nac, napqi, and metamizole may show inaccurate results. the severity depends on the clinical situation and the therapeutic state of the patient. it is good clinical practice not to take blood from a patient immediately after administering medication, except in the case of therapeutic drug monitoring. nevertheless under certain, rare circumstances there is insufficient time between the administration of a drug and blood sampling, which may lead to accuracy issues with the trinder tests.Roche has identified:1. falsely low crea plus results for patients with a toxic level of acetaminophen under treatment with n-acetylcysteine (nac). 2. falsely low results of crea plus after intravenous injection of metamizole.The crea plus results were below the measuring range, while plausible results were obtained with the crea jaffé method.
  • Action
    Laboratories are advised to be aware that the recovery of Trinder tests may be falsely low when the blood sample is taken while levels of NAC, NAPQI, and Metamizole are still present.

Device

Trinder tests on Roche Analysers – Hitachi 902, COBAS c111, COBAS c311/501/502/701/702 & COBAS IN...
  • Modèle / numéro de série
    Trinder tests on Roche Analysers – Hitachi 902, COBAS c111, COBAS c311/501/502/701/702 & COBAS INTEGRA 400 plus/800. An in vitro diagnostic medical device (IVD) · CREA plus, · CREP2, · LACT2, · Lactate, · GLU, · TRIGL/TG, · TRIGGB, · TRIG/GB, · CHOL/CHOL2, · HDL-C plus 3rd generation/HDLC3, · LDL_C plus 2nd generation/LDL_C, UA2/UA plusARTG: 174906, 174908 & 174909
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited