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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01174-1
Product Name/Description	Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An in vitro diagnostic medical device (IVD) Immulite / Immulite 1000 XPi IGF-1 Catalogue Number: L2KGF Siemens Material Number: 10381448 Lot Number: 441-492 Immulite 2000 / Immulite 2000 XPi IGF-1 Catalogue Number: LKGF1 Siemens Material Number: 10381403 Lot Number: 315-334 ARTG Number: 179720
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	21/11/2012
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	The manufacturer confirms a positive shift in patient medians of approximately 20% with the IGF-1 assay. The manufacturer advises that the performance of kit lots currently in distribution is in alignment with the medians of the reference data range published in Instructions for Use. Additionally, Siemens wants to notify customers of an upcoming major supply disruption.
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