Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21041 |
| Brand Name: | Siemens Sysmex CS-2000i, CS-2100i, CS-2500 and CS-5100 Systems |
| Model: | |
| Affected: | 10488064, 10488062, 11239235 and 10709128 respectively. |
| 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 Inc |
| Issue: | The manufacturer has confirmed that under very rare circumstances a false negative result may be reportable. The issue may only occur under the following conditions: 1. The initial result is falsely flagged with an antigen excess error that triggers an automatic reanalysis in a 1/19 dilution. 2. The raw signal that is generated from the reanalysis is below the Limit of Blank (LoB) of the method. 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 |
