Reported Mar 31, 2021 · Terminated
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional…
Caire Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CAIRE DIAGNOSTICS INC · 7020 Koll Center Pkwy · Pleasanton, CA · 94566-3103
Is this the product you have?
- CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** -
- Product Usagea 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
- Lot codes and dates
- All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).
- Amount recalled
- 381 units (171 units U.S. and 210 units O.U.S.)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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