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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00344-1
Product Name/Description	Ki67-MM1 Bond Ready To Use, An in vitro diagnostic medical device (IVD) Product Code: PA0118 Lot number: 28251 Expiry Date: September 2017 Lot number: 29784 Expiry Date: January 2018 Lot number: 29879 Expiry Date: January 2018 Lot number: 29880 Expiry Date: January 2018 Manufactured between September 2014 and January 2015. ARTG Number: 178442
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	20/04/2015
Responsible Entity	Leica Microsystems Pty Ltd
Reason/Issue	Leica Biosystems recently became aware that some lot numbers do not consistently perform as expected and in some instances have exhibited weaker than expected staining. A false negative result could potentially result in the underestimation of the aggressiveness of a neoplasm, the mis-classification of a neoplasm, or failure to distinguish a benign process from a malignant one. Any of these could result in the application of inappropriate treatment or delay in therapy. Laboratories that follow procedures outlined in the products’ instructions for use (IFU) would identify the weak staining or negative staining in the tissue control.
Recall Action	Recall
Recall Action Instructions	Leica Biosystems is advising the users to return any unused product for a credit note. 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 and other diagnostic tests . A review of patient results may be warranted at the discretion of the pathologist. This action ha been closed-out on 31/08/2016.
Contact Information	03 9211 7535 - Leica Biosystems