Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19628 |
| Brand Name: | Radiometer AQURE Data Management System |
| Model: | |
| Affected: | |
| Software version: | all software versions below V2.1.1 |
| Recalling Organisation: | Radiometer Pacific Suite 1 1/30 Benedicts Street Eden Terrace Auckland 1010 |
| Contact Information: | 0800 723 722 |
| Manufacturer: | Radiometer Medical ApS |
| Issue: | Manufacturer has recently become aware of a potential clinical issue with AQURE if the Data Management system is being used to interpret patient results for the management of treatment. In AQURE, there are two views called Flexlink and Patient View. Each can display multiple patient result values from a single patient, provided over time, from one or multiple devices. This screen is intended to be reviewed by a clinician. The issue occurs when a sample type is not provided from a device. An example is where results from a sample type of “Urine” (not displayed) is compared to results from a sample type “Arterial”. In this case a clinician may incorrectly take action based on an assumption that all results are from a sample type “Arterial”. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/1/2016 |
