Database updated: 19 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37690 |
| Brand Name: | Atellica CH and Atellica CI Analysers |
| Model: | Atellica CH HDL Cholesterol (HDLC) and Atellica CH Total Protein_2 (TP_2) |
| Affected: | Material Number - 11537213 and 11537228 All Lots |
| 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 via complaints the potential for reagent carryover on the Atellica CH and Atellica CI Analysers. If carryover occurs, it may affect patient samples, quality control (QC), and/or calibrator results. For the Atellica CH Analyzer: · Carryover from Atellica CH HDL Cholesterol (HDLC) may cause falsely elevated Atellica CH Enzymatic Haemoglobin A1c (A1c_E, A1c_H) results. For the Atellica CI Analyzer: · Carryover from Atellica CH HDL Cholesterol (HDLC) may cause falsely elevated Atellica CH Enzymatic Haemoglobin A1c (A1c_E) results. · Carryover from Atellica CH Total Protein (TP_2) may cause falsely depressed Atellica CH Direct Bilirubin 2 (DBil_2) results. This interaction does not occur on the Atellica CH Analyzer. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/10/2026 |
