BioFire FilmArray Gastrointestinal Panel Recalled for False Positive Results
BioFire Diagnostics is recalling the FilmArray Gastrointestinal (GI) Panel due to elevated rates of false positive results for Campylobacter and Cryptosporidium.
- Product
- FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with…
- Category
- Medical Device
- Distribution
- Distributed nationwide