| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00815-3 |
| Product Name/Description |
Calibrator B from ADVIA Centaur FSH Assay (used with ADVIA Centaur or ADVIA Centaur XP System). An in vitro diagnostic medical device (IVD)
Multiple Ref / Lot numbers & Expiration dates |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Siemens confirmed analytical sensitivity values greater than 0.3mlU/mL described in the Instructions For Use when evaluating multiple lots of the ADVIA Centaur FSH assay and Calibrator B on the ADVIA Centaur and ADVIA Centaur XP system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions for users to follow. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |