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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00316-1
Product Name/Description	Dimension Clinical Chemistry Systems HB1C Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD)) Catalogue Number: DF105A Siemens Material Number (SMN): 10483822 Lot Number: GA3009, GA3141, GA3197, GA3247, GA3113, GA3162, GB3211, GA3267, GA3134, GA3169, GA3232, GB3281, GC3302 ARTG number: 181689
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/04/2013
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%.The issue may impact quality control (QC) materials, patient samples, and proficiency survey samples. 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	Siemens is asking users to destroy affected lots and will replace any recalled units.
Contact Information	1800 310 300 - Siemens Technical Support Centre