BioFire Diagnostics, LLC: Medical Device Recalls in 2019

Updated on March 25, 2026.

According to to data from the FDA, there were 2 medical device recalls made by BioFire Diagnostics, LLC in 2019. See the details of the recalls below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
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 FilmArray systems.