| TGA Action ID |
RC-2025-RN-00905-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
NextSeq 550Dx HO Rgt Kit v2.5 75 & 300 Cycles. An in vitro diagnostic medical device (IVD).
Catalog Numbers: 20028870, 20028871
UDI Numbers: 00816270020132, 00816270020118
Multiple Lot Numbers |
| ARTG Number |
297844 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Illumina has identified a problem with the NextSeq 550Dx flow cell (a component of the NextSeq 550Dx sequencing kits). Loose debris from the NextSeq 550Dx flow cell gasket has caused leakage during sequencing runs. Intermittent liquid leaks were observed beneath the flow cell at various stages, including the start, middle, and end of the run. The affected flow cells may cause a run failure.
Illumina has not received any complaints related to patient/user adverse events. |
| Instructions for Customers/Users |
Impacted sites/users containing the affected lots of the faulty flow cells are requested to dispose of the kits and replacement kits will be provided.
This action has been closed out on 06/08/2026 |
| Action Commencement Date |
22/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 775 688 - Illumina Australia |