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.
From the FDA notice · Read the official notice ↗ · All BioFire Diagnostics recalls
What to do
The agency's notice has the remedy and who to contact.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 23 kits (690 pouches)
- Illnesses reported
- None reported
- Manufactured in
- 515 S Colorow Dr, N/A, Salt Lake City, UT, United States
- Classification
- Class II
- Recall number
- Z-0602-2026
In the FDA's words
- Description
- 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. UDI: 00815381020529 /Lot # 2649724 Distribution: US Nationwide distribution in the states of ID, OR, AZ. Affected quantity: 23 kits (690 pouches)
- Hazard
- Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
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ModerateFDAAug 19, 2026