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 and Phadia 200 Software 1.6.12 [Material Number: 12-4300-00] [HKMD numbers: 210044, 210045, 220204].
According to TGA, 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.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00109-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Feb 2024