| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00344-1 |
| Product Name/Description |
Multiple infectious organism IVDs/ Viruses IVD
Respiratory Pathogens B 16-well Step 2 Plates and Step 1 tubes, Respiratory Pathogens C 16-well Step 2 Plates and Step 1 tubes, Respiratory Pathogens 12-well Step 2 Plates and Step 1 tubes, Respiratory Pathogens 16-Well Step 2 Plates and Step 1 tubes, SARS-CoV-2, Influenza and RSV 8-well Step 2 Plates and Step 1 tubes.
Multiple Catalogue numbers, batch numbers and expiry dates.
ARTG 235809
ARTG 236377 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Batch S3076208 for the product 20612Sv10 and batch: S3076561 for product 80618Sv06, and batch: P3049260 for product 80618Pv06 are exhibiting contamination problem for RSV target.
An inhouse investigation confirmed this finding and additional batches listed in the submission could possibly exhibit similar issue and hence as a precautionary measure they must be quarantined and disposed.
To date, there have been no reports of adverse events related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are requested to inspect stock and quarantine affected stock the products, their respective versions and batches to prevent further use.
Customers are to discard the affected stock and provide confirmation of the disposal of the affected stock.
AusDiagnostics shall provide free of charge replacement of the affected stock after receipt of the acknowledgement form. |
| Contact Information |
02 9698 8030 - AusDiagnostics Support |