NIOX

Circassia AB · Model MINO 09 · UDI-DI 07350047030458

MXA Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX MINO according to guidelines for NO measurement established by the American Thoracic Society.

Recalls

Date	Firm	Reason
2021-02-26	CAIRE DIAGNOSTICS INC	Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readi

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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.