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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01030-1
Product Name/Description	Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD) Catalogue Number: DF105A Siemens Material Number: 10483822 Lot Numbers: GA4266, BA4273, BA4280, BA4287, GA4301, GA4315, GC4322, GA4343, GA4350, GA4357, GA5013 & GA5020 ARTG Number: 181689
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/09/2014
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens has confirmed that the Dimension HB1C Flex reagent cartridge lots listed1 exhibit a positive bias averaging 0.4% [4.4 mmol/mol] Haemoglobin A1c units and occasionally up to 1.0% [11 mmol/mol] HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP).
Recall Action	Recall
Recall Action Instructions	Siemens is advising their customers to discontinue use and discard the affected lots. Retesting HbA1c should be considered in cases where all of the following events have occurred: - HbA1c testing was performed on your patient(s) using the affected lot numbers - There may have been adjustments in therapy based solely on the HbA1c value(s), - There have been no follow up HbA1c testing on the patient since the discontinuation of use of the affected lot numbers. This action has been closed-out on 10/08/2016.
Contact Information	1800 310 300 - Siemens Technical Support Centre