| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01010-1 |
| Product Name/Description |
RX Daytona Plus (with ISE & without ISE). An in vitro diagnostic medical device (IVD)
RX Daytona Plus (with ISE)
Catalogue number: RX4040
GTIN: 05055273207774
RX Daytona Plus (without ISE)
Catalogue number: RX4041
GTIN: 05055273207781
ARTG 204222
(Randox Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
21/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
The RX Daytona Plus Parameter settings have been updated in Parameter version v23. The rerun settings (sample volume Low/High), and dilutions used for Auto reruns have been disabled. Randox are in the process of generating and updating existing data to comply with In-vitro Diagnostic Regulations (IVDR). For samples above the assay range a manual dilution should be performed and results multiplied by the dilution factor.
The RX Daytona plus operator manual has also been updated with Technical Bulletin RXTB-0150 detailing that C1 wash solution RX3973 is pre-diluted no additional dilutions are required. Insert RXTB-0150 into the operator manual to ensure all within your organisation are aware of this update. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to download and update parameters, or manually enter updates to avoid losing any previously obtained data, for assays performed on the Rx Daytona Plus. For samples above the assay range a manual dilution should be performed and results multiplied by the dilution factor. The RX Daytona plus operator manual has also been updated with Technical Bulletin RXTB-0150 detailing that C1 wash solution RX3973 is pre-diluted no additional dilutions are required.
This action has been closed out on 23/02/2024 |
| Contact Information |
02 9615 4640 - Randox Technical Services |