Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 34910 |
| 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 that incorrect software flagging may occur for the Atellica CH RCRP assay that may potentially lead to an erroneous result. The probability of occurrence for an erroneous result in the absence of a flag is less than 0.1%. The probability of occurrence for an erroneous result with an error flag is 1% or less. This issue can present with serum or plasma and with all Atellica CH RCRP reagent lots. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/3/2025 |
