| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00143-1 |
| Product Name/Description |
Low RNA Reagent Cassette. An in vitro diagnostic medical device (IVD)
Catalogue number: 40331 version: 03
Batch numbers: C298133RL, C299183RL, C297907RL, C298045RL
Date of expiry: 26-Sep-2024, 15-Oct-2024, 20-Sep-2024, 25-Sep-2024
ARTG: 236377
(AusDiagnostics Pty Ltd - Multiple infectious organism IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
AusDiagnostics has identified a potential raw material problem leading to background noise / non-specific reactivity of the Parainfluenza virus (PIV) type 1, 2 or 3 targets, which the software is interpreting as positive / detected.
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 remaining affected batches.
AusDiagnostics Pty Ltd will provide replacement stock to customers once the customer acknowledgement form is received. |
| Contact Information |
02 9698 8030 - AusDiagnostics |