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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00824-1
Product Name/Description Bond Polymer Refine Red Detection System. An in vitro diagnostic medical device (Immunohisto chemical staining kit)

Catalogue Number: DS9390

Lot Numbers: 22017
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/08/2013
Responsible Entity Leica Biosystems Melbourne Pty Ltd
Reason/Issue Leica Biosystems has received reports that the product may be contaminated with fungus. This issue could cause loss of staining sensitivity or obstruction of fluid delivery to the slide.
Recall Action Recall
Recall Action Instructions Leica Biosystems is requesting users to remove and discard remaining affected reagents. Affected product will be replaced by Leica Biosystems. A review of patient results reported from the affected lot should be undertaken at the discretion of the laboratory manager.
Contact Information 03 9211 7535 - Leica Biosystems Regulatory Affairs