| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00747-1 |
| Product Name/Description |
Calibrator 30 (2 pack) used with ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, Centaur XP and Centaur XPT systems. An in vitro diagnostic medical device (IVD).
Calibrator 30 Siemens Material Number (SMN): 10379810
Lot Numbers: 00387A21, 16673A21, 36243A21
Expiry: 8 March 2018
ARTG Number: 175698 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
Siemens’ internal investigation has determined that samples with estradiol concentrations of approximately 35 pg/mL (128 pmol/L) and lower exhibit a % bias greater than the expected historical performance of the product when comparing C3021 to C3020. Results observed indicate that as estradiol concentrations increase, the % biases observed become less pronounced. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is advising users to discontinue use of and discard the Calibrator 30 kit lots 00387A21, 16673A21 and 36243A21. Replacement product will be provided. Calibrator 30 kit lots ending in 20 and 23 are not impacted and can be used.
This action has been closed out on 14/02/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |