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 Gastrointestinal (GI) Panel [UDI-DI: 00815381020109; Kit Lot: 1749723; Pouch Lot: 2XKB23; Kit Lot: 1746223; Pouch Lot: 2XJA23] and The BIOFIRE Respiratory Panel 2.1 (RP2.1) [UDI-DI: 00815381020529; Kit Lot: 1667923; Pouch Lot 2X2423; Kit Lot: 1890223; Pouch Lot: 2YHT23] [HKMD numbers: 200384, 210367].
According to the FDA, a manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93526
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Jan 2024