Print version of this report
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