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BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Recalled May 13, 2026 · FDA recall Z-2081-2026 · BioFire Diagnostics

Hazard
Respiratory/sore throat panel test may result in false negative results and control failures. · FDA Class II
Units
2400 pouches
Sold at
US Nationwide distribution in the states of MS, TX MN, VA.

Description

Respiratory/sore throat panel test may result in false negative results and control failures.

Product
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Manufacturer(s)
BioFire Diagnostics, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 | RecallWatchUSA