| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00586-1 |
| Product Name/Description |
RX Daytona Plus (with ISE and without ISE). An in vitro diagnostic medical device (IVD).
Catalogue Number: RX4040 and RX4041
GTIN: 05055273207774 and 05055273207781
ARTG 204222
(Randox Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
RX Daytona Plus Parameter technical ranges have been updated for IGA, IGG, IGM to match the Instructions for Use (IFU). This leads to an inability to report results within the claimed technical range. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to download and update the parameters, or manually enter updates to avoid losing any previously obtained data, for assays performed on the Rx Daytona Plus. |
| Contact Information |
02 9615 4640 - Randox Technical Service |