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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