medical Class II Updated 2024-02-21

BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 tes

Recalled Product

FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.

Hazard / Issue

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part No.: RFIT-ASY-0116 (30 test kit) UDI-DI code: 00815381020109 Part No. RFIT-ASY-0104 (6 test kit) UDI-DI code: 0081538102011
View official government recall

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