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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01010-1
Product Name/Description	Dimension Vista IRON Flex reagent cartridge. An in vitro diagnostic medical device (IVD) Catalogue Number: K3085 - SMN 10445135 Lot Numbers: 11286BA, 11319BB, 12004BB, 12044BC, 12073BB, 12073BC, 12101BC, 12101BD, 12130BB, 12130BC, 12188BD and all future lots ARTG Number: 181689
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/10/2012
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	The sponsor has confirmed the potential for falsely elevated results with IRON Flex reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources.
Recall Action	Recall for Product Correction
Recall Action Instructions	Institute work around
Contact Information	Siemens Technical Support Centre - 1800 310 300