Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26938 |
| Brand Name: | ADVIA Chemistry System |
| Model: | |
| Affected: | Gamma-Glutamyl Transferase - All lots, Gamma-Glutamyl Transferase - 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 the ADVIA Chemistry and Atellica CH Gamma-Glutamyl Transferase (GGT) reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the ADVIA Chemistry and Atellica CH GGT Instructions For Use (IFU) on some analyzers. The increased imprecision is only observed at low concentrations of approximately 27-42 U/L. The imprecision observed at these low concentrations does not impact the mean recovery of quality control material. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/11/2020 |
