| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00273-1 |
| Product Name/Description |
Radiometer immunoassay AQT90FLEX Analyser
ARTG Number: 224867
An in vitro diagnostic medical device (IVD). |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
RADIOMETER has recently become aware of a potential significant clinical issue where a measured parameter with a positive result may be reported as being negative.
The problem may occur in rare situations where the analyser uses an incorrect Hct value equal to 0% possibly due to:
· Incorrect needle calibration in wash block after change of Hct cell.
· Needle not sufficiently tightened after replacement.
Insufficient cleaning causing disrupted flow in the fluid path between wash block and needle.
· Air bubbles in the sample due to use of a different sample tube than recommended. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Radiometer Pacific representative will perform a test to determine if the analyser is affected and perform a correction to eliminate the risk. A software update is under development that will include an analysis process check to eliminate the possibility of this error. End users are requested to ensure that the mandatory ‘System Clean’ is performed regularly as instructed in the AQT90FLEX Instructions For Use. This action has been closed-out on 26/08/2016. |
| Contact Information |
1800 247 254 - Radiometer Pacific |