Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20673 |
| Brand Name: | AutomaticQC Cartridge - Positive Bias tHb Level 1 AQC |
| Model: | |
| Affected: | Lots AQC/19516, AQC/19616, AQC/20816, AQC/20916, AQC/21016, AQC/21416, AQC/21516 |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd 55 Hugo Johnston Drive Penrose Auckland |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Inc |
| Issue: | The manufacturer has confirmed that the lots of AQC have been incorrectly value assigned resulting in a +8 g/L bias for Level 1 tHb on RAPIDPoint 400/405/500 systems. Some users are reporting higher than expected results for this AQC level |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/9/2016 |
