FDAHealthOctober 22, 2025
BioFire Diagnostics, LLC — BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
⚠️ Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Is this relevant to me?
- Geography
- US, AZ, FL, GA, ID, NC, NH, NJ, NY, OR, PA, SC
- Source agency
- FDA
- Category
- Health
- Published
- October 22, 2025
US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
What's affected?
- Product
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Lot code
- 2649724
Additional details
UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 97 Kits (2,910 pouches).
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