BioFire Diagnostics, LLC recalls FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104,
Recalled Product
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Hazard / Issue
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.
Issued by
FDA
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