| 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 |
|
| 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 |