| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00435-1 |
| Product Name/Description |
Synthetic Positive Controls for Atypical Pneumonia. An in vitro diagnostic medical device (IVD)
Batch number: 31404
Catalogue number: 91071
Manufacture date: 01 May 2024
Expiry date: 01 March 2025
ARTG 236377
(AusDiagnostics Pty Ltd - Multiple infectious organism IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
An incorrect material was used during preparation of the Synthetic Positive Controls for Atypical Pneumonia batch: 31404. Reporting of patient results may be delayed if repeat tests are required due to the failure of the Control. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to quarantine and dispose of the affected batch of the product.
AusDiagnostics Pty Ltd will provide replacement stock to customer free of charge after receipt of the acknowledgement form. |
| Contact Information |
02 9698 8030 - AusDiagnostics Pty Ltd Support |