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

Medical DevicesSource: FDA (device) · Date: 2026-05-13

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
BioFire Diagnostics, LLC
Product
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Reason / hazard
Respiratory/sore throat panel test may result in false negative results and control failures.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of MS, TX MN, VA.
Recall initiated
2026-04-01
Code info
Lot Number: 2215125/UDI: 00815381020390
Product quantity
2400 pouches
Voluntary mandated
Voluntary: Firm initiated
City
Salt Lake City
State
UT
Country
United States
Event id
98719
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