Recall – Asthma treatment device produces erroneously high readings

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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