Warning
BioFire Diagnostics Recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2081-2026Medical Device
BioFire Diagnostics Recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
BioFire Diagnostics, LLC · Class II — Moderate Risk
Product Description
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Reason for Recall
Respiratory/sore throat panel test may result in false negative results and control failures.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of MS, TX MN, VA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
BioFire Diagnostics, LLC has recalled a medical device that the FDA classified as Class II affecting 2400 pouches. The recall was initiated on April 1, 2026. Respiratory/sore throat panel test may result in false negative results and control failures. It was distributed in MS, TX MN, VA. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.