Company: CAIRE DIAGNOSTICS INC
Date of Enforcement Report: 3/31/2021
Class II

PRODUCT

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

REASON

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.

RECALLING FIRM/MANUFACTURER

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.)

DISTRIBUTION

U.S. Nationwide and International