FDAFDA · Food and drugs·Recall number Z-1877-2025
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Published June 4, 2025 · Recall initiated: April 30, 2025
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
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioFire Diagnostics, LLC
- Distributor
- International distribution in the country of Singapore.
- Lot
- Lot# 1475424/ UDI: None
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.