Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00499-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00499-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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