Caire Diagnostics Recalls FenomPro Devices Due to Erroneous High FeNO Readings
Caire Diagnostics is recalling FenomPro devices because calibration drift and software errors may cause erroneously high FeNO readings, potentially leading to premature discontinuation of asthma treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves erroneous diagnostic readings that may lead to the premature discontinuation of effective asthma treatment and persistent underlying disease, which constitutes a significant risk of harm to patient health.
Plain-English summary
Caire Diagnostics Inc. is recalling 381 units of the FenomPro REF 900-0001 device, a portable, non-invasive instrument used to measure fractional exhaled nitric oxide (FeNO) in human breath. The recall affects all units sold before February 23, 2021, with serial numbers ranging from 100107 to 100651. The devices were distributed worldwide, including in the United States (California, Colorado, Florida, Texas, and Wisconsin) and in Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, the Philippines, Spain, and Switzerland.
The recall is due to two issues that can cause FeNO scores to be erroneously high: drift in the calibration gases and a software error. Erroneously high FeNO levels may contribute to the premature discontinuation of effective asthma treatment, resulting in persistent underlying disease. The FenomPro device is not intended for use in critical care, emergency care, or anesthesiology.
Consumers and healthcare providers should stop using the affected devices and contact Caire Diagnostics for further instructions on the recall.
The recalled product
- 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.
- Manufacturer
- CAIRE DIAGNOSTICS INC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All units sold before February 23
- 2021 are affected (serial numbers 100107 to 100651).
Distribution
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