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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00700-3
Product Name/Description Sysmex CS-2100i/2000i Systems (Coagulation Analysers), Software Versions: up to and incl. SW 00-60 (CS-2x00i). An in vitro diagnostic medical device (IVD)

Model Numbers: 06317410 (CS-2000i), 06372511 (CS-2100i)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/07/2012
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue The manufacturer of the device, Sysmex Corporation, has informed Siemens Healthcare Diagnostics that in a rare occurrence, data attached with a flag indicating “low reliability” was auto-validated and transferred to the host, when settings of the instrument were such that “low reliability” or flagged data should not be validated. In these cases, the data displayed by the host computer does not include the “low reliability” flag.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing work around instructions for users to implement.
Contact Information 1800 310 300 - Siemens Technical Centre