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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00002-1
Product Name/Description	Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. An in vitro diagnostic medical device (IVD) Immulite/Immulite 1000 Catalogue Number: LKA01 Siemens Material Number: 10381158 Lot Number: 409 and above Immulite 2000/Immulite 2000XPi Catalogue Number: L2KA02 Siemens Material Number: 10381188 Lot Number: 314 and above ARTG Number: 179720
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	2/01/2014
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens Healthcare has confirmed over-recovery of samples with concentrations greater than 5.5ng/mL (19.2nmol/L) with the Immulite/Immulite 1000 and Immulite 2000/ Immulite 2000 XPi Androstenedione assays. Siemens has determined that these lots are linear up to a concentration of 5.5ng/mL (19.2nmol/L), instead of 10ng/mL (34.9nmol/L) as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5ng/mL (19.2nmol/L) and 10ng/mL (34.9nmol/L) will detect this issue.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is advising their customers to use Quality Control materials with at least two levels having concentrations greater that 5.5ng/mL (19.2 nmols/L). Patient values of greater than 5.5ng/mL (19.2 nmols/L) should be verified using an alternate method.
Contact Information	1800 310 300 - Siemens Technical Support Centre