| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00659-1 |
| Product Name/Description |
EZ1 DSP Virus Kit (48). An in vitro diagnostic medical device (IVD)
Catalogue Number: 62724
Lot Numbers: 160017650, 160017770 and 160020069
Corresponding Reagent Cartridge: REAG CART VIRUS (RCV)
Reagent Cartridge Lot Number: 160011000
ARTG Number: 211651
(Qiagen Pty Ltd - General laboratory reagent and consumables IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Qiagen have identified that the kit lots160017650, 160017770, and 160020069 contain a non-conforming EZ1 DSP virus Reagent Cartridge LOT (REG CART VIRUS LOT160011000). In the affected Reagent Cartridges, the Proteinase K Solution in well 10 is missing, i.e. well 10 is empty.
At a maximum, eight of the 48 Reagent Cartridges in one kit are affected. All affected Reagent Cartridges are on Position 6 within the clamshell box. |
| Recall Action |
Recall |
| Recall Action Instructions |
Qiagen is advising users to immediately discontinue use and dispose of kits with lots 160017650, 160017770, 160020069, and/or REAG CART LOT 160011000. Users should contact Qiagen Technical Service to arrange replacement.
This action has been closed out on 10/07/2019 |
| Contact Information |
1800 243 800 - Qiagen |