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 United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning BioFire Diagnostics, LLC BIOFIRE FILMARRAY Pneumonia Panel [REF: RFIT-ASY-0143, RFIT-ASY-0144] [HKMD No.: 200387].
According to the FDA, pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94942
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Aug 2024