FDA-Device2020-03-18Class II
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
BioFire Diagnostics, LLC
Hazard
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
Sold states
US: KY, IL, NJ, MS
Affected count
23 kits (690 pouches)
Manufactured in
515 S Colorow Dr, Salt Lake City, UT, United States
Products
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1451-2020Don't want to check this manually?
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