Class II
Medical Device Recall: BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
BioFire Diagnostics, LLC · April 30, 2025
Reason for Recall
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Distribution
International distribution in the country of Singapore.
States Affected
IN
Quantity Affected
30 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1877-2025
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.