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CAIRE DIAGNOSTICS Recalls

1 recall on record · March 31, 2021 to March 31, 2021 · Medical Devices

March 31, 2021Medical DevicesFDA

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

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.

CAIRE DIAGNOSTICS Recalls | RecallWatchUSA