Home › BIOFIRE DIAGNOSTICS, LLC › FilmArray® Respiratory Panel 2 (RP2)

FilmArray® Respiratory Panel 2 (RP2)

BIOFIRE DIAGNOSTICS, LLC · Model RFIT-ASY-0130 · UDI-DI 00815381020161

OZZ OZY OZX OTG OOU OEP OEM OCC Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

IVD reagent kit containing 6 tests

Recalls

Date	Firm	Reason
2025-03-24	Ortho-Clinical Diagnostics, Inc.	It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
2019-02-20	Luminex Corporation	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially

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 key Read the docs

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.