Lower risk Medical device recall · FDA · Published June 7, 2021

BioFire Pneumonia Test Kits Risk False Negatives After 6 Months

BioFire Diagnostics recalls pneumonia test kits that may give false negative results after 6 months of use. Affected kits have specific part numbers and serial codes. Stop using if expired.

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

🇺🇸 FDA recall #Z-2039-2021Medical device BioFire Diagnostics ›

Lower-risk recall

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

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 certain pneumonia test kits that may produce false negative results after 6 months of the expiration date. This could lead to incorrect health assessments if the test is used on a patient with pneumonia. Read more at govinfonow.com/recall/62377-biofire-pneumonia-test-kits-risk-false-negatives-after-6-months.

Source Summary by GovInfoNow · govinfonow.com/recall/62377-biofire-pneumonia-test-kits-risk-false-negatives-after-6-months · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2039-2021

Cite this page

“BioFire Pneumonia Test Kits Risk False Negatives After 6 Months.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62377-biofire-pneumonia-test-kits-risk-false-negatives-after-6-months. Based on FDA recall #Z-2039-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2039-2021%22&limit=1).

BioFire Diagnostics, LLC voluntarily recalled FilmArray Pneumonia Panels due to potential false negative results, according to the FDA on June 7, 2021.

How to tell if you have it

Brand: BioFire Diagnostics
Product: FilmArray Pneumonia Panel (Pneumo)
Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit)
Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)

The hazard

The recall addresses real-time stability study failures that may cause an increased rate of false negative results between the 6 to 12 month expiry time-frame.

Context

GovInfoNow's records show BioFire Diagnostics, LLC has 32 other recalls on record since March 14, 2018. Other recent recalls include a BioFire Respiratory Panel 2.1 recall for false negatives (June 24, 2026), a BioFire Joint Infection Panel recall for false positives (April 22, 2026), and a BioFire Spotfire Respiratory Panel recall for false negatives (April 1, 2026). Similar recent recalls of diagnostic tests include a Meridian Bioscience Revogene C. difficile Test recall (Dec. 5, 2025) and Biomerieux VITEK 2 AST-N461 and AST-N447 Kit recalls (June 4, 2026 and July 24, 2026).

How to tell if you have this one

Check for part numbers RFIT-ASY-0144 or RFIT-ASY-0145 with serial codes 00815381020178 or 00815381020185. These kits were sold in the U.S. between 2017 and 2018.

Brand
BioFire Diagnostics
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
Terminated
Distribution
U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Algeria, Angola, Anguilla, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece , Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nicaragua, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.

Recall number	Product, codes & lots	Quantity
Z-2039-2021	FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit); Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)	4,462 kits (Globally)
Z-2040-2021	FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit); Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)	3,559 kits (Globally)

Based on the official FDA remedy

What to do — step by step

Check Expiration Date
Verify the test kit's expiration date to ensure it is not expired.

Where it went and when

Where it was distributed

Distributed in 46 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY.…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Jun 7, 2021Firm started the recall
Jul 8, 2021FDA classified it Class II
Jul 14, 2021Published in FDA’s Enforcement Report
Jul 31, 2023FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/62377-biofire-pneumonia-test-kits-risk-false-negatives-after-6-months">BioFire Pneumonia Test Kits Risk False Negatives After 6 Months (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-2039-2021 (June 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2039-2021 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.