BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

Recalled August 28, 2024 · FDA recall Z-2683-2024 · BioFire Diagnostics

Hazard

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer. · FDA Class II

Units

24 Kits

Sold at

Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.

Description

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.

Product

BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

Manufacturer(s)

BioFire Diagnostics, LLC

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