Sysmex XN-10 and XN-20 Automated Haematology Analysers. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00585-1

Class II

2017-05-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00585-1

Roche diagnostics australia has been informed by sysmex asia pacific that misalignment of the protective sheet on sysmex xn-10 and xn-20 analysers may allow potential leakage from fluidic parts to reach the electronic components. this leakage has the potential to result in the build-up of salt deposits on the electronic components which over time may present an internal combustion hazard.There has been one complaint worldwide relating to this issue. to date, no complaints have been received in australia.

Roche Diagnostics is advising customers that during the next immediate future service visit the technician will check the positioning of the protective sheet and verify that there is no leakage from the fluidic parts. If necessary, re-routing of the wiring bundle will be performed to eliminate interference and affected components replaced. In the interim, customers are requested not to attempt to inspect their instruments themselves as this area of the instrument is inaccessible to them.