Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18533 |
| Brand Name: | Siemens Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, and CS-5100 instruments |
| Model: | Catalogue Numbers: OUVV15 & OUVV17 |
| Affected: | First affected lot: 45059 (subsequent lots with higher lot numbers might also be affected), plus 44851 |
| 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: | |
| Issue: | Siemens Healthcare Diagnostics has confirmed that a number of lots can lead to the failure of calibration on Sysmex® CA-1500, CA-7000, CS-2000i, CS-2100i, and CS-5100 instruments. In case the Berichrom Protein C calibration curve on the above mentioned systems is indicated as being invalid due to the 0% point of the calibration by "reaction curve ERROR", the measurement signal does not meet the instrument's check algorithm for at least a value of 0.001dOD and therefore this point gets flagged. 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 |
