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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01023-1
Product Name/Description	IMMULITE/IMMULITE 1000 - Cortisol Assay - An in vitro diagnostic medical device (IVD) Catalogue number: LKCO1 Siemens Material Number: 10381388 Lot Numbers: 381, 382 & 383 ARTG Number: 179720
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	24/09/2014
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens has identified that IMMULITE/IMMULITE 1000 Cortisol kit demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. The positive bias was also observed in Quality Control materials and may result in values outside the established ranges.. The observed positive bias in cortisol values may potentially lead to additional investigation of adrenal status.
Recall Action	Recall
Recall Action Instructions	Siemens are advising users to discontinue use and discard any remaining kits. The issue has been resolved with IMMULITE/IMMULITE 1000 Cortisol kit lots 384 and above (supplied since 1 August, 2014). A look back of previously generated results is at the discretion of laboratory. This action has been closed-out on 12/08/2016.
Contact Information	1800 310 300 - Siemens Technical Support Centre