CAIRE DIAGNOSTICS INC Recall 87445
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.
CAIRE DIAGNOSTICS INC Recall 87445 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1284-2021 |
| Event ID | 87445 |
| Event 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. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 381 units (171 units U.S. and 210 units O.U.S.) |
| Recall Reason | 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 Classification | 20210331 |
| Device Code Info | All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651). |
| Center Classification Date | 20210319 |
| Recall Initiation Date | 20210226 |
| Recalling Firm | CAIRE DIAGNOSTICS INC |
| Initial Notification | |
| Similar To |