Class II

Medical Device Recall: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

BioFire Diagnostics, LLC · June 24, 2026

Reason for Recall

Due to increase in false negative results

Distribution

U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.

States Affected

NATIONWIDE

Quantity Affected

2,370 pouches (79 kits)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2936-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

BioFire Diagnostics, LLC Medical Device Recall: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic | SafeCheck