BioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results
BioFire Diagnostics is recalling 2,370 pouches of the BIOFIRE Respiratory Panel 2.1 test due to an increase in false negative results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (false negative diagnostic results) where specific injury or illness reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
BioFire Diagnostics, LLC is recalling 2,370 pouches (79 kits) of the BIOFIRE Respiratory Panel 2.1 (RP2.1) in vitro diagnostic test. The recall is being conducted due to an increase in false negative results associated with the product.
The affected product is identified by Part Number 423742, UDI-DI code 00815381020529, Pouch Lot 3VLB25, and Kit Lot 1872125. The recall covers U.S. nationwide distribution in the states of Alabama, Arkansas, Iowa, Illinois, Kansas, Louisiana, Minnesota, Missouri, Texas, and Wisconsin.
Healthcare facilities and consumers should stop using the affected product and contact BioFire Diagnostics for further instructions or a replacement.
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
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
Distribution
Related recalls
Same manufacturer · BioFire Diagnostics, LLC
See all →- HighBioFire Joint Infection Panel diagnostic test kit contamination recall
FDA (Devices) · 2026-05-13
- HighBioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
FDA (Devices) · 2026-05-13
- HighRespiratory test panels recalled over elevated risk of false negative results
FDA (Devices) · 2025-12-03
- HighBioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect
FDA (Devices) · 2025-06-04
- HighFilmArra Pneumonia Panel Plus Diagnostic Kit Recalled for Control and Test Failures
FDA (Devices) · 2025-04-16
Same hazard · false negative result
See all →- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighLuminex VERIGENE Gram Negative Blood Culture Test Recalled
FDA (Devices) · 2025-06-11
- HighVERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results
FDA (Devices) · 2023-07-05
- HighMedical device test system recalled for decreased reactivity and false-negative results
FDA (Devices) · 2022-12-07
- HighARIES SARS-CoV-2 Assay Recalled Due to Syringe Defect
FDA (Devices) · 2022-11-02