| TGA Action ID |
RC-2025-RN-01018-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Thermo Fisher Scientific CEDIA Buprenorphine cutoff calibrator, (5 ng/mL). An in vitro diagnostic medical device (IVD).
Catalog Number: CDF100242
Lot Number: 75334868
Expiry: 2026-07-31
UDI: 00884883001718 |
| ARTG Number |
192620 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The CEDIA Buprenorphine cutoff calibrator (5 ng/mL), Lot 75334868, results in a reported concentration of 3.74 ng/mL, which is below the established specification range of 4–6 ng/mL. The cutoff calibrator is 5 ng/mL, however, it is currently recovering at 3.74 ng/mL
There is a potential risk of a false positive result being reported when using the 5 ng/mL cutoff calibrator. This is a screening assay, and all positive results must be confirmed by a secondary method. |
| Instructions for Customers/Users |
Customers can continue to use the product if it meets laboratory requirements.
If the product no longer meets requirements, please contact your Thermo Fisher Scientific Account Manager or the Customer Care Team.
This action has been finalised on 26/10/2026. |
| Action Commencement Date |
8/12/2025 |
| Responsible Entity |
|
| Contact Information |
1300 735 292 - Customer Care Team |