| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00742-1 |
| Product Name/Description |
Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical device (IVD).
Product code: B1029-47
Lot number: C091009
Expiry date: 17 March 2015 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
7/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
As a result of an internal investigation by Trinity BioTech, it has been determined that the symbol to denote 'Harmful' has been omitted from the package insert. The information within the package insert regarding tha handling and disposal of the product is still correct. If the package insert and MSDS is followed correctly there is no risk to the end user when handling or disposing of the kits. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Immuno is advising their customer that the product was supplied without the appropriate symbol to denote "Harmful". End users should be aware that all the information within the package insert is correct including handling and disposal instructions. |
| Contact Information |
1800 252 215 - Immuno Toll Free |