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.
Medical device manufacturer, BioFire Diagnostics, LLC, has issued a medical device safety alert concerning its U BioFire FilmArray Gastrointestinal (GI) Panel with Remel Cary Blair transport medium [Reference Number: RFIT-ASY-0116 and RFIT-ASY-0104] [HKMD No.: 200384].
The manufacturer has identified an increased risk of false positive Vibrio/Vibrio Cholerae results when the BioFire GI Panel is used with certain lots of Remel Cary-Blair transport medium.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 03 Jul 2024