| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00814-1 |
| Product Name/Description |
QIAsymphony DSP DNA Mini Kits. An in vitro diagnostic medical device (IVD).
Catalogue number: 937236
Lot number: 154023773
Reagent cartridge lot number: 154022318
ARTG number: 211651 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Some reagent cartridges (REAG CART) in this kit lot contain a reagent cartridge holder with an incorrect shape. One “fixing projection” between Well 1 and the bead trough is significantly larger and protruding. This could lead to interrupted runs or incorrect sample processing. |
| Recall Action |
Recall |
| Recall Action Instructions |
QIAGEN is advising users to quarantine any remaining stocks of the affected product. Product will be inspected and replaced if affected.
QIAGEN is recommending a review of previously generated results. This action has been closed-out on 20/02/2017. |
| Contact Information |
03 9840 9800 - QIAGEN Technical Services Department |