| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00478-1 |
| Product Name/Description |
Alere DDS2 Test Kits (Drug screening test system). An in vitro diagnostic medical device (IVD)
Catalogue number: DDS2-403
Lot number: 94025 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer's quality control testing has identified a potential issue which could increase the risk of false positive results being obtained for the THC (Cannabis) test on some batches. No other drug test is affected |
| Recall Action |
Recall |
| Recall Action Instructions |
Alere is advising their customers to discontinue use and destroy of the affected kits immediately. |
| Contact Information |
07 3363 7711 - Alere Technical Support |