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 In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel, Panel BioFire Respiratory Panel 2.1 (RP2.1), Panel FilmArray GI Panel [REF: RFIT-ASY-0147, 423742, RFIT-ASY-0116; Part Number: RFIT-ASY-0147, 423742, RFIT-ASY-0116; UDI: 0815381020338, 00815381020482, 00815381020109; Pouch Lot Number: 1766022, 1551622, 1674322] [HKMD No.: 200384, 210367].
According to the FDA, due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=91647
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Mar 2023