| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00275-1 |
| Product Name/Description |
AQURE POC Management System, software versions 1.4.0 to 1.5.3 (An in vitro diagnostic medical device (IVD)) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Patient results are displayed with the incorrect unit of measure in AQURE when:
a) AQURE is changed from the default setting for any or all parameters of International System of Units to use Non-International System of Units (SI Units); and
b) The result is outside reference and critical ranges; and
c) AQURE is being used to view the results.
Results on the analyser and reported to the HIS/LIS remain correct. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised to view patient results in their HIS/LIS system and not in AQURE POC management system. Radiometer will provide an update to software version1.5.4 to correct this issue. |
| Contact Information |
1800 247 254 - Radiometer Pacific |