Events

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

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-00499-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-12
  • 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-00499-1
  • 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
    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.
  • Action
    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