Class II

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

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

24 Kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2683-2024

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.

BioFire Diagnostics, LLC Medical Device Recall: BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 | SafeCheck