Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning PHADIA AB Phadia 200 Instruments [Software version: 1.6.15] [HKMD No.: 210044].
According to the TGA, 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.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00849-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Sep 2024