| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00369-1 |
| Product Name/Description |
ADVIA Centaur Folate Assay
Lots Numbers Ending In/Expiration Date
219 - 25 March, 2014
223 - 12 May, 2014
ARTG Number: 175700 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has confirmed one set of customer complaints related to the performance of the ADVIA Centaur Systems Folate assay, kit lots ending in 223. Customers observed that the third party controls Bio-Rad Liquichek and Bio-Rad Lyphochek Immunoassay Plus Folate serum controls may give rise to out of range low results with the ADVIA Centaur Systems Folate assay kits.
In addition, Siemens has confirmed a second set of customer complaints regarding a shift in whole blood patient results for ADVIA Centaur Systems Folate assay kit lots ending in 219 compared to kit lots ending in 222, 224, 225, 226 and 227. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting their customers to discard all kit lots ending in 219 and 223 and to notify Siemens of any replacement needs. Kit lots ending in 222, 224, 225, 226, 227 and above can continue to be used as they provide accurate folate results. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |