| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00925-1 |
| Product Name/Description |
ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems. An in vitro diagnostic medical device (IVD)
ADVIA Centaur Immunoassay System
Siemens Material Number: Multiple
ADVIA Centaur XP Immunoassay System
Siemens Material Number: Multiple
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified an issue that causes patient demographics data (patient name, age, sex) from the previous order received from the Laboratory Information System (LIS) to be merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full and a particular character (H) is found in the last five locations in the LIS data buffer. In this case, the incorrect patient demographic information will be transmitted to the LIS and will be displayed on the ADVIA Centaur user interface and instrument generated printed reports. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If the ADVIA Centaur and / or ADVIA Centaur XP Immunoassay System is interfaced to a LIS system that transmits patient demographics with each order, the customers are advised to check the event log for the message: “500 03 01 Unknown format message” / rejected results on the LIS. If the message is present, customers are advised to review patient demographic information for all work orders after the time of this event to identify any specific ranges defined for age or sex apply to the order and ensure necessary action is taken for this result.
This action has been closed out on 18/07/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |