| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00984-1 |
| Product Name/Description |
HIV Ag/Ab Combo (CHIV) Assay (used with ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP) (an in vitro diagnostic medical device (IVD))
Catalogue Number: 06520528
Siemens Material Number: 10283020
Multiple lot numbers affected
ARTG Number: 205090 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
25/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has determined that not all distributed lots would meet the performance criteria as currently described in the Instructions for Use (IFU) with respect to the analytical sensitivity. Siemens are updating the labelling to better reflect the observed and potential range of assay performance with respect to this parameter (i.e less than and equal to 2.0 IU/mL). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions for users to follow until the revised Instructions for Use (IFU) are released. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |