| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01195-1 |
| Product Name/Description |
Radiometer AQT90FLEX Immunoassay analyser. An in vitro diagnostic medical device (IVD)
All Serial Numbers
ARTG Number: 224867 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has recently become aware that the internal temperature in the AQT90 FLEX Analyser under worst case conditions may slightly exceed acceptable storage conditions for AQT90 FLEX on-board test cartridges.
Please note that if the AQT90 is exposed to temperatures above the new limit, but still within the old limits, the cartridges are still safe to use. The specifications are only affected with a few % and this is below any clinical significance. No action is required regarding the cartridge.
To ensure that the temperature does not exceed maximum limit, the environmental specifications for the ambient temperature for the AQT90 FLEX Analyser has been adjusted to 30°C/86.0°F (down from 32°C/89.6°F). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. To ensure that the temperature does not exceed maximum limit, the environmental specifications for the ambient temperature for the AQT90 FLEX Analyser has been adjusted to 30°C (down from 32°C).
2. For users:
a. If the ambient temperature is above 30°C r reduce it to below 30°C or move the analyser to another location that is below 30°C
b.Complete and return the supplied Customer Reply form, within 7 days from receipt, to acknowledge this notification and implementation of the required actions.
c. If you are not the end user of the affected product please ensure that this letter is distributed to the final end user.
3. Radiometer will contact users to arrange a suitable time for a Radiometer representative to install a software upgrade V8.9.613.0 or higher. This software upgrade will reduce the heat generated internally and distribute the heat generated more evenly.
4. Users will also be provided with a revised copy of the Instructions For Use (IFU).
This action has been closed out on 27/02/2019 |
| Contact Information |
1800 247 254 - Radiometer Pacific |