| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00672-1 |
| Product Name/Description |
ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP systems
Multiple Catalogue numbers and Lot numbers affected
ARTG Number: 175075
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens have identified that the percent recovery for 1:10 diluted patient sample dilutions is lower than reported in the Instructions for Use (IFU). Dilution of patient samples is primarily used to resolve results above the diagnostic range of the HCY Assay. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising end users to ensure that 1:10 sample dilution testing is no longer carried out. The performance of 1:2 sample dilutions has been confirmed to meet the IFU recoveries and can continue to be tested. This action has been closed-out on 07/09/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |