Company: CAIRE DIAGNOSTICS INC
Date of Enforcement Report: 3/31/2021
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.
Recall Number: Z-1284-2021
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.
CAIRE DIAGNOSTICS INC on 2/26/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
381 units (171 units U.S. and 210 units O.U.S.)
U.S. Nationwide and International