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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01238-1
Product Name/Description IMMULITE 2000 and IMMULITE 2000 XPi

Catalogue number: SMN 10381188

Lot number: 314-323

ARTG number: 179720
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 21/11/2014
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue In December 2013, Siemens Healthcare Diagnostics issued Urgent Recall for Product Correction (TGA Ref. RC-2014-RN-00002-1) for IMMULITE 2000/IMMULITE 2000 XPi Androstenedione due to an observed over-recovery.

During efforts to restore performance of the Androstenedione assay it was confirmed that the issue noted in December 2013 was not limited to samples >5.5 ng/mL (>19.2 nmol/L). Please refer to Figures 1 and 2 for more information. The root cause of the over-recovery is related to the variability of a critical raw material.
Recall Action Recall
Recall Action Instructions Siemens is requesting their customers to discard the affected lot of IMMULITE 2000/IMMULITE 2000 XPi Androstenedione.

A laboratory look back is recommended for any existing androstenedione sample(s) with values generated using the affected reagent lots during the period of time within sample stability labelling, and retesting using an alternate method. This action has been closed-out on 16/05/2017.
Contact Information 1800 310 30 - Siemens Technical Support Center