| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00756-1 |
| Product Name/Description |
ADVIA Centaur anti-TPO and Atellica IM Anti-Thyroid Peroxidase. An in vitro diagnostic medical device (IVD).
Used on ADVIA Centaur XP and XPT Systems and Atellica IM Analysers
ADVIA Centaur anti-TPO
100 Test Lot numbers: 26053337 and 26054337
500 Test Lot numbers: 26051337 and 26052337
Atellica IM Anti-Thyroid Peroxidase
100 Test Lot number: 26098336
500 Test Lot number: 26099336
ARTG 175697
(Siemens Healthcare Pty Ltd- Clinical chemistry autoimmune IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthineers has confirmed a positive bias in the patient results at and below the cut-off of 60 U/mL with the impacted lots on the ADVIA Centaur XP, ADVIA Centaur XPT and Atellica IM analyzer. Falsely elevated aTPO results may be generated as a result of this problem. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should discontinue use of and discard the impacted lots. |
| Contact Information |
Matt Kay on 0438 399 217 or the Siemens Customer Care Center on 1800 310 300. |