FilmArray Pneumonia Panel Plus Test Kits Recalled for False Positive Results
BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a diagnostic test with potential for false positive results. The hazard is theoretical (no reported illnesses or injuries), but the product represents a risk-of-harm where diagnostic inaccuracy could lead to patient harm through misdiagnosis.
Plain-English summary
BioFire Diagnostics, LLC is recalling FilmArray Pneumonia Panel Plus (Pneumoplus) diagnostic test kits (REF: RFIT-ASY-0143, CED 2797) due to a potential for false positive results.
The affected kits include all unexpired lots, with approximately 214,080 pouches distributed worldwide. In the United States, the tests were distributed to all 50 states, the District of Columbia, and Puerto Rico. Internationally, distribution includes Argentina, Bolivia, Brazil, Chile, 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, and Venezuela.
False positive results could lead to incorrect diagnosis of pneumonia in patients who do not have the condition. If you have questions about this recall, contact your healthcare provider for guidance.
The recalled product
- Product
- FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 214,080
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00815381020314/ All unexpired lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · BioFire Diagnostics, LLC
See all →- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- HighBioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results
FDA (Devices) · 2026-08-19
- HighBioFire Joint Infection Panel diagnostic test kit contamination recall
FDA (Devices) · 2026-05-13
Same hazard · false positive results
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- HighQuickVue Dipstick Strep A Test Recalled for False Positive Results
FDA (Devices) · 2026-05-20
- ModerateLeadCare II Blood Lead Test Kit Recall for Inaccurate Results
FDA (Devices) · 2026-04-29
- ModerateLeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results
FDA (Devices) · 2026-04-29
- HighLeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results
FDA (Devices) · 2026-04-29
Similar recalls
- HighFilmArray Pneumonia Diagnostic Kits Recalled for False Negative Results
FDA (Devices) · 2021-07-14
- HighFilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives
FDA (Devices) · 2023-08-30
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- HighFilmArray Pneumonia Panel diagnostic test kits recalled for false results
FDA (Devices) · 2021-06-30
- HighFilmArray Pneumonia Panel Kits Recalled Due to Shelf-Life False Negatives
FDA (Devices) · 2021-07-14
- HighFilmArra Pneumonia Panel Plus Diagnostic Kit Recalled for Control and Test Failures
FDA (Devices) · 2025-04-16