BioFire Pneumonia Panel Plus: False Positive Risk in Testing
BioFire Diagnostics recalls Pneumonia Panel Plus (Pneumoplus) kits due to potential false positive results. Affected kits include all unexpired lots with UDI 00815381020314.
Lower-risk recall
Their is a potential for false positive results when using Pneumonia panel.
Contact the company
What happened, in plain English
BioFire Diagnostics recalls its Pneumonia Panel Plus (Pneumoplus) test kits because they may give false positive results. This could lead to unnecessary treatments or anxiety for users. The recall covers all unexpired lots of the test kits. Read more at govinfonow.com/recall/56558-biofire-pneumonia-panel-plus-false-positive-risk-in-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/56558-biofire-pneumonia-panel-plus-false-positive-risk-in-testing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0993-2024
Cite this page
“BioFire Pneumonia Panel Plus: False Positive Risk in Testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56558-biofire-pneumonia-panel-plus-false-positive-risk-in-testing. Based on FDA recall #Z-0993-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0993-2024%22&limit=1).
Why it’s dangerous
The test kits may produce false positive results when detecting pneumonia, which could lead to unnecessary treatments or anxiety. This happens due to a potential issue with the test's accuracy.
Who’s affected
Healthcare providers and labs using the Pneumonia Panel Plus test kits are likely affected. Those who have recently used the test kits may be at risk of false positive results.
How to tell if you have this one
Check for the product name 'Pneumonia Panel Plus (Pneumoplus)' and the unique device identifier (UDI) 00815381020314. All unexpired lots of this test kit are affected.
- Brand
BioFire Diagnostics- Category
Medical device
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
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Bolivia, Brazil, Chili, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Hong Kong, Honduras, Japan, South Korea, Mexico, Nicaragua, Panama, Peru, Philippines, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, Venezuela.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0993-2024 | FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit); UDI: 00815381020314/ All unexpired lots | 214,080 pouches |
| Z-0994-2024 | FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit); UDI: 00815381020178/ All unexpired lots | 274,290 units |
What to do — step by step
Check Test Kit Details
Verify the product name and UDI number on the test kit packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 44 states.
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the test kits immediately?
No, the recall does not require immediate discontinuation. Affected kits can be checked for the UDI number to determine if they are affected.
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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-0993-2024 (December 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0993-2024 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.