Events

Retiro De Equipo (Recall) de Tina-quant Soluble Transferrin Receptor (STFR): Elevated imprecision with QC Level 1

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-00499-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-12
  • 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-00499-1
  • 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
    Stfr reagent lots# 606453 and 606449 may show elevated imprecision and possible high recovery of stfr control set level 1. this issue can lead to a bias in the stfr results (max + 11%, min-15.1%) in patient samples.In case of erroneous high stfr results, unnecessary further examination of erythropoesis and iron status are possible. however, no treatment decision should be based on stfr values alone. medical history, further findings and other parameters such as transferrin, reticulocyte count, iron, hb, heamatocrit, mcv, ldh, ferritin should be taken into account. in case of the erroneous low/normal results a delay in differential diagnosis of anaemic condition cannot be excluded.
  • Acción
    Roche Diagnostics is requesting their customers to discontinue use of Tina quant Soluble Transferrin Receptor (STFR) Lot# 606453 and Tina quant Soluble Transferrin Receptor (STFR) Lot # 606449. Replacement will be sent to laboratories free of charge. This action has been closed-out on 17/08/2016.

Device

Tina-quant Soluble Transferrin Receptor (STFR): Elevated imprecision with QC Level 1

Manufacturer

Roche Diagnostics Australia Pty Limited