| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00155-1 |
| Product Name/Description |
therascreen MGMT Pyro Kit. An in vitro diagnostic medical device (IVD)
Catalogue number: 971061
Lot numbers: 175030723, 175034299
ARTG 226453
(Qiagen Pty Ltd - Acquired genetic alteration IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
The methylated control DNA LOT 175028686 for use with the therascreen MGMT Pyro Kit is not showing any signals when using Pyrosequencing technology on the PyroMark Q24 System.
The Methylated control DNA LOT 175028686 cannot be properly amplified during the PCR amplification step and thus is not showing any signals when using Pyrosequencing technology on the PyroMark Q24 System. This issue is limited to this one specific LOT of methylated DNA control (175028686) and does not affect other samples. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to cease use of and discard remaining stock of the therascreen MGMT Pyro Kit (48) LOTs 175030723 and 175034299. |
| Contact Information |
0439 713 500 – David McLean |