| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00765-3 |
| Product Name/Description |
ADVIA Centaur Multi-Diluent 1 supplied with ADVIA Centaur BNP kit and ADVIA Centaur TSH-3 Ultra kit; An in vitro diagnostic medical device (IVD)
REF: 2 pack - 07293184 (110312) and 6 pack - 0790714 (110313)
Multiple Lot Numbers
Supplied with:
ADVIA Centaur BNP kit
REF: 02816634 and 02816138
ADVIA Centaur TSH-3 Ultra kit
REF: 06491080 and 06491072
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed a decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems. This under-recovery has been observed in plasma samples with high BNP and TSH-3 values that require dilution to achieve results within the reportable range on the ADVIA Centaur and ADVIA Centaur XP systems. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is providing work around instructions for users to follow. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |