| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00576-1 |
| Product Name/Description |
VITEK 2 Software. An in vitro diagnostic medical device (IVD)
KIT, VITEK 2 UPDATE 09.03 ML
Reference number: 423887
Lot number: 9.03
KIT, VITEK 2 UPDATE 09.04 ML
Reference number: 424327
Lot number: 9.04
KIT, UPDT VTK2 09.01/ 09.02
Reference number: 423487
Lot number: 9.01/9.02
ARTG 227811
(Biomerieux Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
A software anomaly may occur while using a specific workflow (non-recommended) to edit Accession IDs (Lab IDs) of on an isolate, or a batch of isolates, while using the Firefox web browser.
The problem is isolated to the Firefox browser while using any released VITEK 2 Software Systems version (9.0x and does not affect future releases) Microsoft Edge and Chrome browsers are not impacted and confirmed by testing. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
Save Accession number by clicking outside the field or press Enter after a change is made, and not use the arrow key.
Please note that this problem only occurs when using Firefox, not with Edge and Chrome browsers. Continue to use good practice and perform changes on one isolate at a time.
This has been corrected in 10.0.1 (10MR1 – Maintenance Release). Firefox will no longer be the default browser for future software releases, however the problem will not recur in the FireFox browser after installation of 10.0.1. |
| Contact Information |
1800 333 421 - HelpDesk |