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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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