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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00499-1
Product Name/Description	Tina-quant Soluble Transferrin Receptor (STFR): Elevated imprecision with QC Level 1 ARTG Number: 174908
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/06/2015
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	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.
Contact Information	1800 645 619 National Support Centre