| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00296-1 |
| Product Name/Description |
Human Assayed Multi-Sera Level 3. An in vitro diagnostic medical device (IVD)
Multiple catalogue numbers, batch numbers, expiry dates and manufacturing dates
ARTG 207886
(Randox Australia Pty Ltd - Multiple clinical chemistry constituent IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
15/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
The analyte NEFA concentration has increased over the shelf life of the product. The targets and ranges need to be reassigned accordingly. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The value sheets have been updated and are available on www.randox.com. Users should discard the previous version and download the updated version. |
| Contact Information |
(02) 9615 4640 - Randox Australia |