| TGA Action ID |
RC-2026-RN-00868-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Brilliance MRSA 2 agar plates. An in vitro diagnostic medical device (IVD).
Item Number: PP2475
Batch Number: 4567009
Expiry Date: 20/10/2026 |
| ARTG Number |
214128 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Investigation found that a raw material picking error resulted in an incorrect dehydrated media base being used to manufacture a batch of Brilliance MRSA 2 agar plates.
The affected plates may fail to produce the expected denim blue colonies for MRSA and may allow breakthrough growth of Enterococcus that resembles MRSA, potentially resulting in false negative or false positive results. |
| Instructions for Customers/Users |
Customers are to:
- Destroy any affected product remaining in inventory or return it to Thermo Fisher Scientific.
- If the affected product has been used, review the results for any anomalies. |
| Action Commencement Date |
27/10/2026 |
| Responsible Entity |
|
| Contact Information |
0498 395 115 - Naresh Jagtap, Thermo Fisher Scientific |