| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00849-1 |
| Product Name/Description |
Phadia 200 Instruments. An in vitro diagnostic medical device (IVD)
Software version: 1.6.15
ARTG's 229542, 192561 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is a problem with the automatic dispensing of dilution wells when performing monthly maintenance of Phadia 200 instruments.
This error is linked to software version 1.6.15 (released in May 2024) leading to the wash nozzles on the wash rake to not be cleaned properly during the monthly maintenance procedure.
According to the Phadia 200 user manual, the operator needs to manually remove the dilution wells after ended monthly maintenance program.
If the error occurs, the dilution wells will be missing, and the operator will notice that the wells were never dispensed although no error message had appeared.
If the wells are not present, the outside of the wash nozzles and the inside of the outer pipe will not be soaked in maintenance solution during the monthly cleaning.
If not addressed, this problem could lead to residues building up over time.
This may cause vacuum problems due to clogging and/or false positive/negative results due to carry over. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers must stop using the automatic dispense-function of dilution wells for the monthly maintenance procedure.
Before starting the Monthly maintenance procedure make sure that the carrier tray does not contain Dilution Wells carrier. If a dilution well carrier has been scanned in previously, make sure to clear it from the tray.
Abacus dx representative will contact customers once the new Phadia 200 software version is released.
The instructions outlined in the Customer Letter should be used until the new software update is installed. |
| Contact Information |
1800 222 287 - Abacus dx Pty Ltd |