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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