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 Beckman Coulter Inc Access Hybritech p2PSA assay. An in vitro diagnostic medical device (IVD) [Reference numbers: B03704 and A49752; Lot numbers: 234320, 234134 and 234133] [HKMD No.: 200378].
According to the TGA, it has been determined that the affected products include an insufficient concentration of blocking reagent. Patient samples tested with the reagent lots listed above may demonstrate repeatable falsely elevated results, which are caused by insufficiently blocked interferents.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00461-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 May 2023