| TGA Action ID |
RC-2025-RN-00416-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator. An in vitro diagnostic medical device (IVD).
Catalog numbers: 10995498 & 10310376
Lot numbers: 86236A74, 44206A75, 86237A74, 44207A75, 25675A77, 44505A78, 52364A79 & above
Expiry Dates: 14/05/2025, 25/09/2025, 01/04/2026, 20/05/2026 & 20/06/2026 |
| ARTG Number |
175075 |
| Unique Device Identifier (UDI) |
00630414598253, 00630414468198 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator Lots listed in the product description do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability.
As the calibrator ages, homocysteine results were observed to increase with bias up to 19.2% at 8 months post manufacture.
The problem may lead to falsely elevated patient results as the calibrator deteriorates over time. |
| Instructions for Customers/Users |
Customers are to:
- Discontinue use and discard affected lots.
- Review your inventory of these products to determine your laboratory’s replacement needs.
- Discuss with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
Atellica IM and ADVIA Centaur Homocysteine Calibrator Lots ending in 74, 75 and 77 are no longer available for purchase. Alternate Atellica IM and ADVIA Centaur Homocysteine Calibrator lots are available from Siemens Healthcare Pty Ltd Australia.
Update 11/05/2026
For lots ending in 78 and 79:
- Immediately discontinue use and discard these kit lots.
For lots ending in 80 and above:
- Immediately store unopened inventory and newly received shipments of these lots in a freezer (-15°C to -25°C).
- To prepare the Calibrators: Allow the calibrator materials to thaw and bring to room temperature before use. Gently mix and invert the vials to ensure homogeneity of the material. |
| Action Commencement Date |
23/04/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |