NIOX

Circassia AB · Model NIOX VERO Test Kit 500 · UDI-DI 07350047030700

MXA Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (500). Also contains sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient.

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.