BioFire Diagnostics, LLC recalls FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0

Recalled August 18, 2021 · FDA recall Z-2245-2021 · BioFire Diagnostics

Hazard

Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error. · FDA Class II

Units

29 kits

Sold at

U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None

Description

Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.

Product

FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127

Manufacturer(s)

BioFire Diagnostics, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →