Quidel Corp. said it found no testing site- or product-related issues with the Sofia 2 instrument or the Sofia SARS Antigen FIA after concluding an investigation regarding a report of discordant results at a Vermont testing location.
- The results of the investigation determined that no further actions were necessary, and results were provided to the Vermont Department of Health, the Centers for Disease Control and Prevention, and the FDA
- Quidel currently sells the Sofia SARS Antigen FIA in the U.S. under Emergency Use Authorization by the FDA
To view the source of this information click
To contact the reporter ...