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BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Recalled April 26, 2023 · FDA recall Z-1392-2023 · BioFire Diagnostics
Hazard
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. · FDA Class II
Units
900 pouches (30 kits)
Sold at
US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.
Description
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Product
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →