Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14221 |
| Brand Name: | Siemens Sysmex CS-2000i/2100i Systems with Thomborel S |
| Model: | Catalogue and Material Nos. OUHP295 / 10446442 & OUHP495 / 10446445 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Products GmbH |
| Issue: | The manufacturer has confirmed that with Sysmex CS-2000i and CS-2100i Systems the last (up to 4) measurements out of a Thromborel S vial may be erroneously prolonged (longer PT sec., lowered % of Norm, increased INR). This may occur if the reagent in the vial is nearly used up and has been placed on board of the Sysmex CS-2000i/CS-2100i Systems for more than 4 hours. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/2/2013 |
