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FDAAugust 8, 2019device

FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

biofire diagnosticsbiofire

UPCs

00815381020116

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only — Recall Details · AllClear