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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01073-1
Product Name/Description Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnostic medical device (IVD)

Siemens Material Number : 10488064, 10488062

All software versions

ARTG Number:179939
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/08/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.

This action has been closed out on the 29/10/2018.
Contact Information 1800 310 300 - Siemens Technical Support Centre