| TGA Action ID |
RC-2026-RN-00621-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
MicroVue SC5b-9 Plus EIA. An in vitro diagnostic medical device (IVD)
Product code: A029
Lot: 13020221
Expiry: 28-FEB-2027 |
| ARTG Number |
203666 |
| Unique Device Identifier (UDI) |
30014613337485 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
QuidelOrtho received complaints about discrepancies in patient correlation results with percent differences compared to the previous lot. We have confirmed a high bias between samples from the previous lot and lot 13020221.
The observed lot-to-lot bias affects plasma samples with SC5b-9 concentrations approximately between 88 ng/mL and 260 ng/mL. Within this range, results generated with the affected reagent lot may be positively biased, with an average observed bias of approximately +46.8%. Falsely elevated patient results could result in inappropriate demonstration of elevated terminal complement activation, which could impact patient management.
As of 27 July 2026, QuidelOrtho has received 4 complaints relating to this problem with no reports of adverse effects. |
| Instructions for Customers/Users |
Customers are to:
- Discontinue use, render unusable, and discard all remaining inventory of affected stock.
- Review the content of the Customer Letter with a Medical Director.
- Complete and return the Confirmation of Receipt form. |
| Action Commencement Date |
19/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - Technical Services Center |