Factor IX coagulation studies on the BCS / BCS XP Automated Blood Coagulation Analyser (Actin, Actin FSL and Pathromtin SL) 의 리콜

Recall

RC-2015-RN-00368-1

Class II

2015-04-28

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00368-1

Siemens has detected a situation with bcs / bcs xp analysers regarding factor ix assay determinations for haemophilia b patients. internal investigations showed discrepancies for siemens bcs / bcs xp within dilution studies. siemens has confirmed that samples at the lower measurement range were found elevated on the bcs/bcs xp system. patient results in the lower measuring range may be misclassified within a higher factor ix level. patients that have been evaluated for hereditary factor ix deficiency disease for the first time may have to be re-evaluated.A falsely elevated factor ix level may lead to a delay in diagnosis of a bleeding disorder related to factor ix deficiency. this may lead to additional diagnostic testing and delayed prophylactic therapy.

Siemens has provided a workaround for users along with a technical support contact number, whilst a permanent fix is being developed. Customers are advised to follow their laboratory protocol regarding the need for review of previously reported patient results. This action has been closed-out on 01/03/2018.