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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00028-1
Product Name/Description Novocastra Liquid Mouse Monoclonal Antibody. An in vitro diagnostic medical device (IVD)

Product Code: NCL-L-CD15

Lot Number: 6015073

Expiry Date: 2014-03
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 16/01/2014
Responsible Entity Leica Biosystems Melbourne Pty Ltd
Reason/Issue Leica Biosystems recently became aware that the product listed above does 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. There is a remote risk of a patient being diagnosed with incorrect tumour based on a false negative CD15 staining result.
Recall Action Recall
Recall Action Instructions Leica Biosystems is advising users to destroy any remaining unused stock. Leica Biosystems is advising users that clinical interpretation of staining or its absence should be evaluated within the context of the patient's clinical history. If this is not the case, clinicians may wish to review results obtained with the affected lot.
Contact Information 03 9211 7535 - Leica Biosystems