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BioFire® Joint Infection (JI) Panel

BIOFIRE DIAGNOSTICS, LLC · Model RFIT-ASY-0138 · UDI-DI 00815381020192

QSN Prescription
1
510(k) clearances
11
Adverse events
1
Recalls
1
Facilities

Description

IVD reagent kit containing 30 kits.

Recalls

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

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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.