| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00109-1 |
| Product Name/Description |
Phadia 200 and Phadia 200 Software 1.6.12. An in vitro diagnostic medical device (IVD).
Material Number: 12-4300-00
All Serial Numbers
ARTG 192561
(Abacus dx Pty Ltd - Instrument/analyser IVDs)
ARTG 229542
(Abacus dx Pty Ltd - Software IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
9/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
As a result of a software update (version 1.6.12) changes were made within the function that empties the instrument of liquids after an assay has finished.
Draining of the process chamber, which is done by vacuum is altered so that several vacuum valves are opened simultaneously. This means that the draining process might not be as effective as before, which can sometimes lead to residual liquid in the process chamber.
When starting up the next assay run, sensors can react on the residual liquid and give false error messages but will not cause any false positive or false negative test results, as the P200 instrument will pause the assay until the error messages has been cleared by the user. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A new software version will be released (anticipated April 2024) to rectify this issue.
In the interim, customers should refer to the instructions in the Customer Letter on clearing error messages when they appear. |
| Contact Information |
1800 222 287 - Abacus dx |