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 Epocal Inc. epoc NXS Host [Software Version: From 4.9.4 to the current version 4.11.11] [HKMD No.: 210419].
According to the TGA, the manufacturer has confirmed a potential issue that could occur under specific conditions when the (automatic) Delete Blood Tests feature is enabled.
When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00978-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Nov 2023