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MEDICAL DEVICE RECALLMODERATE
Biofire Spotfire Respiratory/Sore Throat Panel
BioFire is recalling the Spotfire Respiratory/Sore Throat Panel due to the risk of false negative results and control failures.
What to do
Contact your healthcare provider or laboratory supervisor to determine if your facility is using the affected test panels and to discuss alternative testing options.
Why it was recalled
Respiratory/sore throat panel test may result in false negative results and control failures.
How to identify it
UPC 00815381020390
Biofire Spotfire Respiratory/Sore Throat Panel
Where it was sold
Distributed in US.
Official source
Other recent recalls from BioFire Diagnostics, LLC
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification