| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00163-1 |
| Product Name/Description |
Evidence MultiSTAT. An in vitro diagnostic medical device (IVD)
Catalogue number: EV4115
ARTG 204223
(Randox Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Randox Australia Pty Ltd is advising of a new mandatory update of the Evidence MultiSTAT software version 3.7, which is now available and will correct several problems detailed in the Customer Letter.
If the software update is not performed there may be risks to health associated, such as the software not running smoothly and delay in testing due to instrument malfunction. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers must complete the mandatory software upgrade by contacting the Randox technical services to obtain the OneDrive link to the software update.
Customers need to know that Tier 1 software update is available for all users, whereas Tier 2 can be purchased for those wishing to perform quantitative assays. |
| Contact Information |
02 9615 4640 - Randox technical services |