| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00382-1 |
| Product Name/Description |
Randox Analysers. An in vitro diagnostic medical device (IVD)
Multiple devices, catalogue numbers and GTINs
ARTG's 204223, 204222 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
14/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
In line with IVDR, Randox Laboratories have added a statement to all instrument manuals, advising all laboratories operating any Randox analysers of the procedure to follow in the event of an adverse incident. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customer's are advised of the updated information to the Instructions For Use, with the addition of a protocol to follow in case of an adverse incident. |
| Contact Information |
02 9615 4640 - Randox Technical Services |