FDA Device Intelligence
Home › Device types › QSN

Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

FDA product code QSN · Class 2 · Microbiology

2
Registered devices
9
Adverse events
1
Recalls
1
510(k) clearances

Devices with this code

BioFire® Joint Infection (JI) Panel — BIOFIRE DIAGNOSTICS, LLCBioFire® Joint Infection (JI) Panel — BIOFIRE DIAGNOSTICS, LLC

Recent recalls

DateFirmReason
2026-04-22BioFire Diagnostics, LLCContamination to in-vitro diagnostic test may result in false positives.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.