Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01073-1

Class II

2016-08-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01073-1

There is the potential for mismatched sample id's under a rare circumstance where the host computer connected to the instrument sends a measurement order irregularly to the instrument. the host computer displays a 'time out' error and when measuring the next sample displays the error 'host computer order is wrong' and overwrites the previous sample id with the current sample being measured. there is the potential for a mis-diagnosis as a result of the error, however there have been no reported injuries as a result of the issue.

Siemens is advising users to repeat the measurement of all samples in an affected sample rack when the instrument displays the error 'HC Order is wrong". A look-back at patient results is at the discretion of the laboratory director. If the error occurs, users should contact the Host Computer Vendor to confirm the interface protocol is running correctly.