Class II
Medical Device Recall: BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
BioFire Diagnostics, LLC · June 10, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
58
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2682-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.