| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00021-1 |
| Product Name/Description |
ARCHITECT Testosterone Reagent, ARCHITECT Testosterone Calibrators and ARCHITECT Testosterone Controls. An in vitro diagnostic medical device (IVD)
List numbers: 7K73-20, 7K73-25, 7K73-01, 7K73-10
Multiple serial / lot numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
The current labels and package inserts for these products do not contain the warnings and precautions applicable to material containing methylisothiazolones which are classified as skin sensitisers. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott Diagnostics is providing an update to the instructions for use advising users to ensure personal protective equipment is used as per the laboratories standard practices. |
| Contact Information |
1800 816 696 - Abbott Customer Support |