Events

Retiro De Equipo (Recall) 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)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00398-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00398-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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