Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23612 |
| Brand Name: | ADVIA® Chemistry Systems |
| Model: | |
| Affected: | Creatine Kinase (CK_L) Reagent Lots 433549 and 439212 |
| 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 a negative bias with patient and quality control results when using the ADVIA Chemistry Creatine Kinase (CK_L) reagent kit on the ADVIA® 1800, 2400, and XPT Chemistry Systems. Customers may also observe an increased incidence of system generated flags (U, u, n). |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/9/2018 |
