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

Recall date

August 8, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1451-2020

FDA classification

Class II

Brand / firm

BioFire Diagnostics, LLC

Sold / distributed

US: KY, IL, NJ, MS

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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