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 Hangzhou Clongene Biotech Co., Ltd. (APAC Security Pty Ltd) Clungene COVID-19 Antigen Rapid Test [Product Code: ISCOVu002-B005] [HKMD number: 220347, 220145].
According to the TGA, the manufacturer has received several complaints regarding discolouration of the extraction reagent tube from a clear solution to a yellow-brown colour.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00827-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Sep 2024