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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00476-1
Product Name/Description Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) (An in vitro Diagnostic Medical Device (IVD)

Product Code: PA0025

Lot Number: 24963

Expiry Date: 17 Dec 2014
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 24/04/2014
Responsible Entity Leica Biosystems Melbourne Pty Ltd
Reason/Issue Leica Biosystems recently became aware that the affected product does not function as intended up to the expiry date on the product labelling.
This was detected through stability monitoring carried out by Leica Biosystems. There is a link between the age of the product and staining intensity.
Recall Action Recall
Recall Action Instructions Leica is requesting their customers to destroy any unused reagent from lot 24963 and confirm that the affected product is no longer in use.
Contact Information 03 9211 7535 Leica Biosystems Melbourne Pty Ltd