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 Reagent Kit [Lot number: 51503FN00] [HKMD No.: 190362].
According to TGA, the manufacturer has identified a few cartridges within Alinity i HBsAg Reagent Kit that may exhibit variability in relative light unit response and concentration values which may result in controls out of range, and/or incorrect patient results. Positive control out of range low results and/or negative control out of range high results could occur when using an impacted cartridge.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-01075-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Dec 2023