FDAFDA · Food and drugs·Recall number Z-2081-2026
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Published May 13, 2026 · Recall initiated: April 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Respiratory/sore throat panel test may result in false negative results and control failures.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- BioFire Diagnostics, LLC
- Distributor
- US Nationwide distribution in the states of MS, TX MN, VA.
- Lot
- Lot Number: 2215125/UDI: 00815381020390
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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