| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00143-1 |
| Product Name/Description |
ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. An in vitro diagnostic medical device (IVD)
Adenovirus R-gene Quantification Standard (QS) and Sensitivity Control (SC)
Refernece Number: 69-010B
Lot Number: 1005056960
Expiry date: 25/08/2018
Parechovirus R-gene Postive control (PC20)
Reference Number: 71-020
Lot Number: 1005090480
Expiry Date: 31/08/2018
ARTG Number: 211361
(Biomerieux Australia - Viral infectious disease IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that a proportion of kits in the ARGENE range have been mislabelled, where the target name is missing from the tube label. The kits are colour coded by reference to minimise the risk of mixing tubes from different references. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
BioMerieux is advising users that the affected product can continue to be used. Users are reminded that the affected products are colour coded by reference, and include the reference number on the labelling.
This action has been closed out on 12/02/2019 |
| Contact Information |
1800 333 421 - Customer Service Support |