CAIRE Diagnostics recalls FenomPro devices sold before Feb 2021 due to inaccurate FeNO readings that could lead to improper asthma management. Affected units have serial numbers 100107-100651.
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 FenomPro devices sold before February 23, 2021 that may give falsely high FeNO readings. This could cause asthma treatment to be stopped prematurely or disease to worsen. The issue comes from calibration drift and software errors in the device.
The device may show higher FeNO levels than actual, which could lead to stopping effective asthma treatment too early. This might cause persistent asthma symptoms or worsen underlying disease. The problem comes from two sources: calibration gases drifting and a software error.
People using the FenomPro device for asthma monitoring are affected. Those with asthma who rely on the device for treatment monitoring are most at risk.
Check for serial numbers between 100107 and 100651. The device was sold before February 23, 2021. It measures fractional exhaled nitric oxide for asthma monitoring.
Look for serial numbers between 100107 and 100651 on the device.
If you have an affected device, stop using it immediately to avoid inaccurate asthma treatment readings.
The FenomPro device may give falsely high FeNO readings due to calibration drift and a software error, which could lead to stopping effective asthma treatment prematurely.
Check your device's serial number. If it's between 100107 and 100651, stop using it immediately and contact CAIRE Diagnostics for further instructions.
No, the device may give inaccurate readings that could affect asthma treatment. It should not be used for critical care, emergency care, or anesthesiology.
We’ve drafted a message you can send CAIRE Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1284-2021 — CAIRE Diagnostics CAIRE Diagnostics Hello, I own a CAIRE Diagnostics that is covered by recall Z-1284-2021 from CAIRE Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
