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 FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems [Ref: RFIT-ASY-0116, Pouch Lot number 2N3R22 / Kit Lot number 2160422; UDI-DI: (00)815381020109] [HKMD No.: 200384]
According to the FDA, due to manufacturing issue, Gastrointestinal Panel may result in false negative results.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=91892.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Apr 2023