Recalling firm
BioFire Diagnostics, LLC
Product type
Device
Status
Ongoing
Report date
2026-05-13
Distribution
US Nationwide distribution in the states of MS, TX MN, VA.
Firm state
UT
Product quantity
2400 pouches
Initiated by
Voluntary: Firm initiated
Reason for recall
Respiratory/sore throat panel test may result in false negative results and control failures.
Product description
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Code / lot info
Lot Number: 2215125/UDI: 00815381020390
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.