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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00925-1
Product Name/Description Immulite 2000, 2000 XPi EBV-EBNA IgG Assay; An in vitro diagnostic medical device (IVD)

Catalogue Number: L2KEB2

Lot Numbers: 215 and above
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/09/2012
Responsible Entity Siemens Ltd
Reason/Issue The manufacturer has identified that lot to lot variability has resulted in the relative specificity not meeting the product Instructions for Use (IFU) claims.
Recall Action Recall for Product Correction
Recall Action Instructions Update to IFU claims. This action has been closed-out on 28/04/2016.
Contact Information 1800 310 300 - Siemens Technical Support Centre