| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00273-1 |
| Product Name/Description |
Respiratory Pathogens (16-well) Step 1 Tubes. An in vitro diagnostic medical device (IVD)
Catalogue numbers: 20620S, 20613S
Batch numbers: S3108211, S3106493
Expiry dates: 05 Mar 2025, 03 Mar 2025
ARTG's 235809, 236377 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
AusDiagnostics has identified a contamination problem for RSV-B target. The problem is a non-specific amplification that happens to melt in the range of genuine RSV. Reporting of patient results may be delayed if repeat test/s are required.
To date, there have been no reports of adverse events related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to quarantine and dispose of the affected batches as per local policy.
AusDiagnostics Pty Ltd will provide replacement stock to customers after receipt of the acknowledgement form. |
| Contact Information |
02 9698 8030 - AusDiagnostics |