FilmArra Pneumonia Panel Plus Diagnostic Kit Recalled for Control and Test Failures
BioFire Diagnostics is recalling 29 units of the FilmArra Pneumonia Panel Plus test kit due to control failures and false negative results. Affected units (Lot 0979424) were distributed to France, Italy, Spain, Switzerland, and Israel.
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: FDA Class II recall with no reported illnesses or injuries in the source. The hazard involves false negative test results in a pneumonia diagnostic kit and control failures that could prevent test validation, representing a risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
BioFire Diagnostics, LLC is recalling 29 units of the FilmArra Pneumonia Panel Plus (Pneumoplus) diagnostic test kit, Reference RFIT-LBL-0374, Lot 0979424. This multiplexed nucleic acid test is designed to diagnose pneumonia infections.
The recall addresses an increased risk of control failures and false negative test results. Control failures prevent proper validation of test results, while false negatives allow infected patients to remain undiagnosed.
The affected units were distributed internationally to France, Italy, Spain, Switzerland, and Israel.
The recalled product
- Product
- FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 29
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/Lot# 0979424
Distribution
Distribution scope not specified by the agency.
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 negative results
See all →- HighBioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
FDA (Devices) · 2026-05-13
- HighBD COR system software issue could produce possible false negative results
FDA (Devices) · 2025-07-30
- HighBioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect
FDA (Devices) · 2025-06-04
- HighCandida ID Antigen recalled for reduced sensitivity, potential false negatives
FDA (Devices) · 2025-03-26
- HighBD SARS-CoV-2 Reagent Kits Recalled for False Negative Test Results
FDA (Devices) · 2024-06-12
Similar recalls
- HighFilmArray Pneumonia Diagnostic Kits Recalled for False Negative Results
FDA (Devices) · 2021-07-14
- HighFilmArray Pneumonia Panel Plus Test Kits Recalled for False Positive Results
FDA (Devices) · 2024-02-14
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- HighFDA Recalls BioFire Pneumonia Diagnostic Test Kits for Control Failures
FDA (Devices) · 2024-08-28
- HighFilmArray Pneumonia Panel diagnostic test kits recalled for false results
FDA (Devices) · 2021-06-30
- HighFilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives
FDA (Devices) · 2023-08-30