Recall Z-1284-2021— CAIRE DIAGNOSTICS INC
Class II · Terminated
Class II FDA medical device recall by CAIRE DIAGNOSTICS INC, initiated 2021-02-26, terminated 2023-03-24. It names one FDA 510(k) clearance: K182874. 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.. 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
- CAIRE DIAGNOSTICS INC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-26
- Terminated
- 2023-03-24
- Firm location
- Pleasanton, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.