ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (An in vitro diagnostic medical device (IVD)) 의 리콜

Recall

RC-2014-RN-00925-1

Class II

2014-08-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00925-1

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.

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.