| TGA Action ID |
RC-2025-RN-00569-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
INNOVANCE VWF Ac Assay. An in vitro diagnostic medical device (IVD)
Used with: BCS XP System, CA-600 series, CS-2500 System, CS-5100 System, CN-3000 System, CN-6000 System
Material number: 10487040
All unexpired lots |
| ARTG Number |
178560 |
| Unique Device Identifier (UDI) |
00842768028014 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The quality control and patient sample results for INNOVANCE VWF Ac might be falsely elevated, independent of the system and reagent lot used.
An increased number of complaints for the test INNOVANCE VWF Ac were received, where customers complained of quality control recovery problems for Control Plasma P (CPP). Results were found above the permitted range according to Table of Assigned Values.
There is a potential of elevated INNOVANCE VWF Ac patient results where quality control is within the permitted range. |
| Instructions for Customers/Users |
Customers are to follow the new INNOVANCE VWF Ac target values for lots within shelf-life contained in the customer letter.
Review the contents of the customer letter with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. |
| Action Commencement Date |
20/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |