Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20749 |
| Brand Name: | Siemens ADVIA Chemistry Calibrator |
| Model: | |
| Affected: | Lot numbers 680726, 680726A, 680726B, 680726C and 680726D |
| 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 DBIL_2 Assigned Calibrator Values (ACV) may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for Direct Bilirubin measurement. Due to the proportional bias, the differences become greater as the concentration of DBIL_2 increases. Quality control (QC) material is also affected by this issue. Depending on the quality control concentrations and ranges used by the laboratory, quality control may not detect this issue. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/10/2016 |
