| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00154-1 |
| Product Name/Description |
Elecsys Troponin T hs Elecsys Troponin T hs STAT. An in vitro diagnostic medical device (IVD)
Elecsys Troponin T hs (08469717190)
Elecsys Troponin T hs STAT(08469814190)
Elecsys Troponin T hs (08469873190)
Elecsys Troponin T hs (09315322190)
Elecsys Troponin T hs STAT (09315349190)
Elecsys Troponin T hs (09315357190)
ARTG 203369
(Roche Diagnostics Australia Pty Limited - Troponin IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
During internal studies with the Elecsys Troponin T hs (high sensitive)/ Elecsys Troponin T hs STAT assay, discrepant elevated assay results were observed for K2 EDTA plasma samples.
The reproducibility of the falsely elevated results and the fact that not all investigated primary tubes show this phenomenon indicate that an interference mechanism caused by pre-analytical issues with the affected primary tubes is the likely root cause.
In some cases, affected samples showed observable turbidity and a pellet fraction was visible after centrifugation of affected samples.
Previous action: RC-2023-RN-00081-1
This new action is to notify customers that the Instructions for Use (IFU) have been updated, thus reducing the risk of false-positive clinical results for patients. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The Instructions for Use (IFU) of Elecsys TnT hs have been updated to add one additional centrifugation step for K2/K3 EDTA plasma samples to avoid any issue in the future. |
| Contact Information |
1800 645 619 - Roche Diagnostics Australia National Support Centre |