| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00878-1 |
| Product Name/Description |
ADVIA Centaur CP – BNP
Catalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)
Siemens Material Numbers (SMN): 10309044 and 10309045
Lot Numbers: lots ending in 172 (Expiration date: 17 April 2015)
ARTG Number: 175075 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has received complaints of failed calibrations on the ADVIA Centaur® CP system when using BNP kit lots ending in 172. Siemens has confirmed that the failed calibration is due to an error on the ADVIA Centaur CP master curve card. The master curve card error results in a low calibration deviation outside the specified calibration evaluation range when using kit lots ending in 172 on the ADVIA Centaur CP. An invalid calibration status will prevent BNP results from being generated and may delay the time to result for BNP. If the calibration is successful, the results will be valid and there is no risk to health. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising that if a successful calibration is achieved with BNP kit lots ending in 172 and quality control results are in range, you can continue to report patient results. If unable to obtain a successful calibration on the ADVIA Centaur CP with BNP kit lots ending in 172, please switch to an alternate lot of BNP. This action has been closed-out on 31/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |