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 Siemens Healthcare Diagnostics Inc. ADVIA Centaur anti-TPO and Atellica IM Anti-Thyroid Peroxidase [HKMD number: 240033].
According to the TGA, the manufacturer has confirmed a positive bias in the patient results at and below the cut-off of 60 U/mL with the impacted lots on the ADVIA Centaur XP, ADVIA Centaur XPT and Atellica IM analyzer. Falsely elevated aTPO results may be generated as a result of this problem.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00756-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 Aug 2024