| 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 |
|
| 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 |