Lower risk Medical device recall · FDA · Published November 27, 2023

BioFire Respiratory Panel 2.1: False negatives may lead to incorrect treatment

BioFire recalls Respiratory Panel 2.1 kits that may give false negative results, risking incorrect antibiotic use or delayed treatment for infections.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0704-2024Medical device BioFire ›

Lower-risk recall

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

Take action

Contact the company

Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248

✎ GovInfoNow plain-language explainer

BioFire Diagnostics recalls its Respiratory Panel 2.1 test kits because they might give false negative results. This could lead to people not getting proper treatment for infections or using antibiotics incorrectly. Read more at govinfonow.com/recall/56765-biofire-respiratory-panel-2-1-false-negatives-may-lead-to.

Source Summary by GovInfoNow · govinfonow.com/recall/56765-biofire-respiratory-panel-2-1-false-negatives-may-lead-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0704-2024

Cite this page

“BioFire Respiratory Panel 2.1: False negatives may lead to incorrect treatment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56765-biofire-respiratory-panel-2-1-false-negatives-may-lead-to. Based on FDA recall #Z-0704-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0704-2024%22&limit=1).

The FDA announced on November 27, 2023, that BioFire Diagnostics, LLC is recalling The BIOFIRE Respiratory Panel 2.1 due to a manufacturing event causing false negative results. This defect may lead to inappropriate antibiotic treatment or delayed identification of infections.

How to tell if you have it

Brand: BioFire
Product: The BIOFIRE Respiratory Panel 2.1 (RP2.1)
UDI-DI: 00815381020529
Lot/Pouch/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024
Quantity: 57 Kits

The hazard

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel. This could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection. It may also result in delayed identification of an outbreak and additional transmission.

Context

GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since March 14, 2018. Recent BioFire recalls include false negative results in the Respiratory Panel 2.1 (June 24, 2026) and false positives in the Joint Infection Panel (April 22, 2026). Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel Recall (July 16, 2026), Meridian Bioscience Revogene C. difficile Test Recall (December 5, 2025), and Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026).

How to tell if you have this one

Check the kit's lot number on the packaging. The kits were sold with lot numbers 1667923 (expiring June 26, 2024) or 1890223 (expiring July 26, 2024).

Brand
BioFire
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD

Recall number	Product, codes & lots	Quantity
Z-0703-2024	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.; UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6, 2024; 1746223/2XJA23/July 6, 2024	53 Kits
Z-0704-2024	The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.; UDI-DI: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024	57 Kits

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for lot numbers 1667923 or 1890223 on the packaging.

Where it went and when

Where it was distributed

Distributed in 16 states.

FDA distribution: “US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Connecticut, Florida, Illinois, Iowa, Kansas, Maryland, Massachusetts, Missouri, Nebraska, New Jersey, North Carolina, Ohio, Tennessee, Texas, Utah.

Recall timeline

FDA published this recall 51 days after the firm started it.

Nov 27, 2023Firm started the recall
Jan 10, 2024FDA classified it Class II
Jan 17, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these kits immediately?

No, the recall does not require immediate discontinuation. The kits can be used but may give false negatives.

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Link to this recall

<a href="https://govinfonow.com/recall/56765-biofire-respiratory-panel-2-1-false-negatives-may-lead-to">BioFire Respiratory Panel 2.1: False negatives may lead to incorrect treatment (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0704-2024 (November 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0704-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.