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BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Recalled August 28, 2024 · FDA recall Z-2682-2024 · 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
58
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, REF: RFIT-ASY-0144
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →