medical Class II Updated 2020-03-18

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

Affected States: KY, IL, NJ, MS
Lot/Code Info: Kit Lot: 0537319 / Pouch Lot: 681619 Pouch Lot Date of Expiration 2020-05-30
View official government recall

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