| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01365-1 |
| Product Name/Description |
Radiometer ABL90Flex analysers running V3.1MR1 or below
ARTG Number: 228382
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has recently become aware of a potential significant clinical issue with patient results if the inlet is left open after aspiration of the patient sample for more than 30 seconds.
If the inlet is accidentally left open after processing a patient sample the ABL90 analyser sounds a warning bell, places a warning message on the screen and also initiates a voice message continuously repeating “Please close the inlet”
The problem can occur after the following sequence of actions:
1. The operator aspirates patient sample A and forgets to close the inlet
2. The inlet is left open for more than 30 seconds before it is closed
3. An operator aspirates patient sample B
In this case the results for patient sample B are affected by this issue.
Radiometer is currently developing a mechanism to be included in a future software upgrade to eliminate the possibility of this error. A label to be attached to the machine is provided to re-inforce the correct instructions for use. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Operators are reminded of the requirement to close the inlet when prompted by the analyser, as per the labelling and the Operator Manual.
In the event the inlet is left open by mistake, a series of corrective steps is provided to customers as an interim measure. A warning label is also provided to customers to attach to the machine to re-inforce the correct instructions for use.
Customers are advised that a look back over previous results may be required at the discretion of the Medical Director
Radiometer is currently developing a mechanism to be included in a future software upgrade that will eliminate the possibility of this error. This action has been closed-out on 20/04/2017. |
| Contact Information |
1800 247 254 - Radiometer Pacific Pty Ltd |