| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00033-1 |
| Product Name/Description |
ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-Ultra
In vitro diagnostic medical devices
ADVIA Centaur BNP (100 tests)
Catalogue: 02816138
SMN Number: 10309044
Kit Lot Numbers ending in: 192,193,196
ADVIA Centaur TSH3-Ultra (100 tests)
Catalogue: 06491072
SMN Numbers: 10282378
Kit Lot Numbers ending in: 298, 301
ADVIA Centaur TSH3-Ultra (500 tests)
Catalogue: 06491080
SMN Number: 10282378
Kit Lot Numbers ending in: 298,301
ARTG Number 175075 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified the following issues:
- The ADVIA Centaur CP, XP and XPT systems will not expire the Multi-Diluent 15 pack at the end of the required 7-day On Board Stability (OBS), if any of the affected BNP or TSH3UL lots are present on the system(s) when performing on-board dilutions; and.
- On the ADVIA Centaur XPT only, the system becomes inoperable under the following scenario: 1) Scanning the Master Curve Card of ADVIA Centaur BNP kit lots ending in 193 or higher or ADVIA Centaur TSH3-Ultra kit lots ending in 301 or higher, and 2) Processing a BNP or TSH3UL onboard dilution of a sample. In this case, the system may display an “Unknown State” message and requires customer action. When this error occurs, any tests that are in-process would have to be repeated. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens is advising customers who use ALL ADVIA Centaur Systems:
- Do not perform onboard dilutions on any ADVIA Centaur system if any of the affected product kit lots are present on the system
- Onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assay(s) are only supported when using ADVIA Centaur BNP kit lots ending in 210 and above and ADVIA Centaur TSH3UL kit lots ending in 310 and above.
If users intend to perform onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assays, users must restart the workstation after scanning the master curve card for the BNP and/or TSH3UL assay kit lot, before ordering an onboard dilution for these assays.
If any of the affected BNP kit lots or TSH3UL kit lots have been in use on the system, users must manually track the time that the Multi-Diluent 15 has been in use on board the system.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 310 300 - Customer Support Centre |