FDAHealthApril 1, 2026
BioFire Diagnostics, LLC — Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
⚠️ Respiratory/sore throat panel test may result in false negative results and control failures.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 1, 2026
US Nationwide distribution in the states of MS, TX MN, VA.
What's affected?
- Product
- Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Lot code
- 2215125/UDI:
Additional details
Lot Number: 2215125/UDI: 00815381020390
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2400 pouches.
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