| TGA Action ID |
RC-2025-RN-00231-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ID NOW COVID-19 2.0 24T. An in vitro diagnostic medical device (IVD).
List Number: 192-000
GTIN: 00811877011354
Lot Numbers: 000M914119, 000M915352 |
| ARTG Number |
345457 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
Abbott Diagnostics Scarborough, Inc. is currently conducting an urgent recall on select lots of ID NOW COVID-19 2.0. The impacted lots (000M914119 and 000M915352) have been confired to have a higher occurrence of invalid rates when compared to the product Instructions for Use. The problem has been isolated to specific sample receiver devices, which were assembled into the kit lots 000M914119 and 000M915352.
The invalid test results are considered minor in severity and may potentially cause temporary delays in patient diagnosis and treatment. |
| Instructions for Customers/Users |
· Customers should discontinue using impacted inventory and destroy any remaining inventory of the impacted lots in accordance with their procedures
· Customers must complete and return the customer reply to receive a replacement lot for the impact lot
· Customers are requested to inform others in the network if they have forwarded this message to others in the network and ask them to take the appropriate action.
This action has been finalised on 6/06/2025. |
| Action Commencement Date |
19/03/2025 |
| Responsible Entity |
|
| Contact Information |
07 3363 7100 - Michael Gunter |