FDA-Device2023-04-26Class II
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
BioFire Diagnostics, LLC
Hazard
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Sold states
US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.
Affected count
900 pouches (30 kits)
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1392-2023Don't want to check this manually?
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