Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37399 |
| Brand Name: | Atellica CH Revised C-Reactive Protein (RCRP) |
| Model: | |
| Affected: | 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 through the investigation of customer complaints the potential for falsely elevated results when the Atellica CH Revised C-Reactive Protein (RCRP) assay is used on the Atellica CH and Atellica CI analyzers. A small subset of samples may reproducibly generate one of the following outcomes: 1. A falsely elevated, reportable result. 2. An initial falsely elevated result above the measuring interval (>25.00 mg/dL or >250.0 mg/L), followed by a 5X auto-diluted result that is inconsistent with the initial result. In this scenario, the auto-diluted result is non-reportable and flagged with Conc Error or < Measuring Interval. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/8/2026 |
