CAIRE DIAGNOSTICS INC recalls CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional…

Recall date

February 26, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1284-2021

FDA classification

Class II

Brand / firm

CAIRE DIAGNOSTICS INC

Sold / distributed

Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, TX, and WI. In the countries of Belgium, Canada, Croatia/Hrvatska, France, Germany, Greece, Hong Kong, India, Philippines, Spain, Spain and Switzerland.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.