| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00827-1 |
| Product Name/Description |
Clungene COVID-19 Antigen Rapid Test (For Self-Testing). An in vitro diagnostic medical device (IVD)
Product Code: ISCOVu002-B005
Lot numbers: 2022120002, 2022120003, 2022120011, 2022120013
ARTG 333341
(APAC Security Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs) |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
25/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
APAC Security Pty Ltd has received several complaints regarding discolouration of the extraction reagent tube from a clear solution to a yellow-brown colour. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
· Inspect their stock immediately and quarantine affected stock on hand to prevent further use.
· Contact APAC Security Ltd on (02) 9986 2252 or support@apacsecurity.com before returning any affected stock.
· Upon confirmation from APAC Security Ltd, return affected stock on hand with the completed response form. APAC Security Pty Ltd will replace all extraction reagent tubes with correct stock when returning affected Clungene COVID-19 Antigen Rapid Test (For Self-Testing). |
| Contact Information |
03 9887 6412 - Anne Saletti-Hayes |