BioFire Respiratory Panel 2.1 test recalled over false negative results
BioFire Diagnostics is recalling certain lots of its BIOFIRE Respiratory Panel 2.1 (RP2.1) test, a lab test that detects respiratory infections. The company found an increase in false negative results, meaning the test can miss an infection that is actually present. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All BioFire Diagnostics recalls
What to do
- Check whether your lab or clinic has REF 423742, pouch lot 3VLB25, or kit lot 1872125.
- If you have affected lots, contact BioFire Diagnostics for guidance before using the remaining kits.
- Ask your healthcare provider to consider the result with your symptoms if a negative test seems inconsistent with how you feel.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 2,370 pouches (79 kits)
- Illnesses reported
- None reported
- Manufactured in
- 515 S Colorow Dr, Salt Lake City, UT, United States
- Classification
- Class II
- Recall number
- Z-2936-2026
In the FDA's words
- Description
- BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic Due to increase in false negative results Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125 Distribution: U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI. Affected quantity: 2,370 pouches (79 kits)
- Hazard
- Due to increase in false negative results