FDAFebruary 26, 2021device

CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readings: 1) Drift in the calibration gases and 2) Software error. Each of these issues can cause FeNO scores/results to be erroneously high.

What to do

FDA enforcement status: Terminated

Brands named

caire diagnosticscaire

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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