Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16396 |
| Brand Name: | Siemens Sysmex CS-2100i Automated Blood Coagulation Analyzer |
| Model: | Catalogue number 10488062 |
| 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: | Sysmex Corporation |
| Issue: | Under certain circumstances an issue with an irregular curve that has not been flagged accordingly may lead to an erroneousdly increased result with a Factor V111 Chromogenic assay. Follow-up communication The manufacturer has issued a new protocol disc version with new and enhanced assay applications for Sysmex CS-2000i/CS-2100i Systems. This also includes a new protocol disc version with new and enhanced assay applications for Sysmex CS-2500 Systems and on Sysmex CS-5100 systems. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 10/7/2018 |
