CLASS II Device recall · Reported 31 Mar 2021 · FDA Enforcement Report
Caire Diagnostics FenomPro REF 900-0001 SN ***** - Product Usage recalled
Caire Diagnostics is recalling Caire Diagnostics FenomPro, distributed nationwide in the US. The recall was initiated on 26 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1284-2021
- FDA event ID
- 87445
- Recalling firm
- Caire Diagnostics, Pleasanton, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2021
- FDA classified
- 19 Mar 2021
- Reported
- 31 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Feb 2021 | Recall initiated by company | |
| 19 Mar 2021 | Classified by FDA | +21 days |
| 31 Mar 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, TX, and WI. In the countries of Belgium, Canada, Croatia/Hrvatska, France, Germany, Greece, Hong Kong, India, Philippines, Spain, Spain and Switzerland.
Questions about this recall
Is Caire Diagnostics FenomPro REF 900-0001 SN ***** - Product Usage: a recalled?
Yes. Caire Diagnostics recalled Caire Diagnostics FenomPro REF 900-0001 SN ***** - Product Usage: a on 26 Feb 2021. The recall is Class II and its status is Terminated. Recall number Z-1284-2021.
Why was it recalled?
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.
Which lots are affected?
All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, TX, and WI. In the countries of Belgium, Canada, Croatia/Hrvatska, France, Germany, Greece, Hong Kong, India, Philippines, Spain, Spain and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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