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BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code recall

BioFire Diagnostics, LLC recalled BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code on August 19, 2026 because of due to increase in false negative results. It was sold nationwide.

Why it was recalled

Due to increase in false negative results

What's recalled

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

Quantity: 2,370 pouches (79 kits)

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
BioFire Diagnostics, LLC, Salt Lake City, UT
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
Status
Ongoing
Recall number
Z-2936-2026
Source
U.S. Food and Drug Administration

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