| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00015-2 |
| Product Name/Description |
AQURE data management system |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential clinical issue with AQURE if the data management system is being used to interpret patient results for the management of treatment.
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) are 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”. This may lead to wrongful diagnosis and wrongful treatment of the patient which can result in immediate as well as long term critical health consequences for the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor will contact the affected customers to arrange for the installation of a database script which will mitigate the risk as a temporary measure. A final solution involving a software upgrade will be provided to the customers when it becomes available. In the meantime, the AQURE system can continue to be used but users are advised to interpret blank fields for sample type as "not specified". |
| Contact Information |
1800 247 254 - Radiometer Pacific |