Lower Respiratory Microbial Nucleic Acid Detection System
Microbiology · 21 CFR 866.3985
Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
4 recall events for this product code
- BioFire Diagnostics, LLCOpen, ClassifiedFeb 6, 2024
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Their is a potential for false positive results when using Pneumonia panel.
Z-0994-2024 · View FDA record ↗ - BioFire Diagnostics, LLCOpen, ClassifiedAug 21, 2023
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Due to manufacturing issue, panels may result in false negative results.
Z-2440-2023 · View FDA record ↗ - BioFire Diagnostics, LLCTerminatedUnknown
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Z-1944-2021 · View FDA record ↗ - BioFire Diagnostics, LLCTerminatedUnknown
FilmArray Pneumonia Panel (Pneumo)
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
Z-2039-2021 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code