| 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 |
|
| 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 |