Z-1284-2021 Class II Terminated
FDA device recall Z-1284-2021 was initiated by CAIRE DIAGNOSTICS INC on February 26, 2021 and is designated Class II. 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 th… The recall status is terminated (terminated March 24, 2023). Affected quantity: 381 units (171 units U.S. and 210 units O.U.S.).
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- February 26, 2021
- Termination Date
- March 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 381 units (171 units U.S. and 210 units O.U.S.)
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.
Distribution Pattern
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.
Code Information
All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).