| TGA Action ID |
RC-2025-RN-00951-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ORTHO VISION BioVue Cassettes and Max Analyser for BioVue Cassettes. An in vitro diagnostic medical device (IVD)
Analyser for BioVue Cassettes
Product code: 6904579
Max Analyser for BioVue Cassettes
Product code: 6904578
Sera Anti-N
Product Code: 6904495 |
| ARTG Number |
281981, 343753 |
| Unique Device Identifier (UDI) |
10758750012831, 10758750012848 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
ORTHO VISION BioVue Analysers may be able to process non-validated tests when they are left on an incorrectly configured regional setting after being reformatted or after new software is loaded. For example, the setting allows the ORTHO Sera Anti-N test to be run on the BioVue Analyzer although it has not been validated for use on the ORTHO VISION BioVue automated platform.
There may be a risk to patient results if ORTHO Sera Anti-N was processed on an analyser where it is not validated, and the ORTHO VISION could potentially produce incorrect results. A false positive result could result in patient injury if an antigen-negative individual is transfused with antigen-positive blood, potentially resulting in haemolytic transfusion reactions. |
| Instructions for Customers/Users |
- Do not process the Ortho Sera Anti-N assay on Vision BioVue Analyzers unless it is part of a User Defined Protocol (UDP).
- QuidelOrtho will confirm the correct configuration is present, remotely or via site visit. |
| Action Commencement Date |
11/11/2025 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - Technical Services Centre |