| TGA Action ID |
RC-2025-RN-00480-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Xpert Norovirus. An in vitro diagnostic medical device (IVD).
Part Number: GXNOV-CE-10
Batch Number: 1001468835
Lot Number: 19901
Expiry Date: 07-Jun-2026 |
| ARTG Number |
222922 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Cepheid has received customer complaints regarding E5007 (probe check too low) errors when using Xpert Norovirus. Investigations have revealed that a subset of Norovirus cartridges was manufactured with an incorrect reaction tube, potentially leading to E5007 errors.
For completed test results without an E5007 error, there are no expected performance differences between cartridges with different reaction tubes. |
| Instructions for Customers/Users |
Customers should check their current inventory for affected lots and may continue using the product, provided it contains the correct reaction tube.
Norovirus cartridges with an incorrect reaction tube should not be used.
Cepheid will supply replacement products for any cartridges with incorrect reaction tubes.
This action has been closed out on 14/10/2025. |
| Action Commencement Date |
20/05/2025 |
| Responsible Entity |
|
| Contact Information |
1800 130 821 - Technical Support |