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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00315-1
Product Name/Description HbA1c Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)

Catalogue Number: K3105A
Siemens Material Number (SMN): 10470481
Lot numbers: 12072AA, 12086AA, 12107AA, 12128AA, 12150AA, 12191AA, 12212AA, 12226AA, 12248AA, 12261AA, 12282AA, 12303AA
ARTG: 181689
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 9/04/2013
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue Issue 1 - Siemens Healthcare Diagnostics have confirmed a positive bias for values below 6%, there is a positive bias of 0.3% with an upper 95% confidence interval of 0.7%.
Issue 2 - Siemens Healthcare Diagnostics have confirmed a higher frequency of "Above Assay Range" flags. There is a higher frequency of flags is related to higher recoveries of sample haemoglobin (Hb) values (Hb >25g/dL or >15.5mmol/L). The Hb value is used to calculate the final output HbA1c ratio (% HbA1c [mmol/mol] result. Results are suppressed (not reported) with the "Above Assay Range" flag.
Recall Action Recall
Recall Action Instructions Customers should immediately discard any remaining inventory of the affected lots of Dimension Vista® HbA1c (K3105A). Siemens will replace any unused inventory of the affected lots at no charge. Siemens is recommending customers to discuss the issues with their Medical Director to determine if additional follow up is appropriate for patient tests conducted with the lots affected.
Contact Information 1800 310 300 - Siemens Technical Support Centre