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 Abbott Ireland Diagnostics Division Alinity i HBsAg Controls and ARCHITECT HBsAg Controls [List Number: 08P0810 & 6C36-10] [HKMD number: 120506, 190362].
According to the TGA, some positive control 2 vials of Alinity i HBsAg Control Kit, ARCHITECT HBsAg Control Kit, may contain a fungal contaminant which could result in aspiration errors.
Abbott received complaints associated with this issue due to aspiration errors and/or material clogging the dispensing tip of the Positive Control 2 (PC2) vial, also with reports of visible material in the PC2 component only.
There is no impact to patient results and to date, there have been no reports of adverse events related to this issue.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00765-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 02 Sep 2024