Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17063 |
| Brand Name: | Sysmex CS-2000i, CS-2100i and CS-5100 Automated blood coagulation analysers |
| Model: | Catalogue number - 10488064, 10488062 and 10709128 respectively |
| 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: | The manufacturer has confirmed a carry-over risk on Sysmex CS systems due to the applications using CA-Clean I (964-0631-3) for sample probe rinse. Under certain circumstances the carry-over might impact results for Factor V with Innovin®, Factor XII with Dade® Actin® FSL, Berichrom F XIII, INNOVANCE® D-Dimer assays. 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. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 10/7/2018 |
