| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01281-1 |
| Product Name/Description |
QIAsymphony DSP Virus/Pathogen Midi Kit. An in vitro Diagnostic Medical Device (IVD)
(DNA/RNA purification system)
Lot Number: 148028163 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Some reagent cartridges (REAG CART) of this kit lot contain reagent troughs that are not filled correctly. This leads to decreased quality of the resulting nucleic acids. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are advised to discard any remaining affected lots of QIAsymphony DSP Virus/Pathogen reagent. It is also recommend that results from samples processed on the QIAsymphony using the affected reagent are reviewed. This action has been closed-out on 15/07/2016. |
| Contact Information |
03 9840 4821 - Qiagen |