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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00214-1
Product Name/Description IMMULITE 2500 IGF-I (An in vitro diagnostic medical device (IVD))

Catalogue Number: L5KGF2

Siemens Material Number: 10381367

Lot Numbers: 189 - 227

ARTG Number: 179720
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/03/2013
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue Siemens confirm a negative bias in patient medians of approximately 5 to 20% using the IGF-I assay as compared to the reference range medians provided in the IGF-I Instructions for Use (IFU) with kit lots released August 2008 through July 2011.
Recall Action Recall for Product Correction
Recall Action Instructions Laboratories to implement the work-around provided by the sponsor. A review of previously reported results should be considered.
Contact Information 1800 310 300 - Siemens Technical Support Centre