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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00003-1
Product Name/Description	Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. An in vitro diagnostic medical device (IVD) Immulite/Immulite 1000 Total IgE Test Code: TIE Catalogue Number: LKIE1 Seimens Material Number: 10380867 Lot Number: 326 and above Immulite 2000/Immulite 2000 XPi Total IgE Test Code: TIE Catalogue Number: L2KIE2, L2KIE6 Siemens Material Number: 10380873, 10380872 Lot Number: 260 and above ARTG Number: 179719
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/01/2014
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens has confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the Immulite Systems Total IgE assays. The Immulite Total IgE controls will not detect this bias. This issue is not expected to impact patient care since the observed bias in values would not impact selection for Omalizumab therapy for asthma.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is providing laboratories with this information to allow informed clinical decisions when undertaking Total IgE testing. There are currently no unaffected batches available in Australia. A lookback of previously generated results is a the discretion of the laboratory.
Contact Information	1800 310 300 - Siemens Technical Support Centre