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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00892-1
Product Name/Description	Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical device (IVD). Product Code: CD10-270-CE Lot Number: 6032742 ARTG Number: 178442
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	14/09/2015
Responsible Entity	Leica Microsystems Pty Ltd
Reason/Issue	Leica Biosystems recently became aware that the Novocastra Lyophilised Mouse Monoclonal Antibody CD10 reagent lots do not function as intended up to the expiry date on the product labelling. There is a link between the age of the product and staining intensity, which may result in inadequate staining and lead to weak or false negative pathology results. This could potentially result in misclassification of a neoplasm and inappropriate management.
Recall Action	Recall
Recall Action Instructions	Leica Biosystems is advising users to cease use and destroy any remaining stocks of affected product. A review of previously obtained results is recommended at the discretion of the laboratory director and physician. This action has been closed-out on 03/03/2017.
Contact Information	03 9211 7535 - Leica Biosystems