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.

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.

Between 02/21-26/2021, the firm contacted its customers via email/phone and Zoom to inform them that two calibration errors were noted for the Asthma Monitor regarding, 1) drift in calibration gases and 2) a software error that may cause a high reading indicating that a therapeutic action should be taken. This may result in prescription of unneeded medication to the patient. On 02/26/2021, the firm sent a follow-up "Urgent - Medical Device Recall" Notification further instructing the customers to: 1. Discontinue use of the device. Make all personnel who use it aware of this recall. 2. Contact Recalling Firm or their distributor. Contact at +1-888-609-4839 or [email protected]. The Recalling Firm will arrange for shipment of the device back to the factory for a software update and re-calibration. If the customer purchased the affected products from a distributor, they should contact them to arrange shipment. 3. Distributors: Please cease distribution of the device and contact the Recalling Firm to arrange for return of their existing inventory for a software update and re-calibration, or device replacement. Distributors should immediately forward the Recall Notification to all affected customers and request that they comply with the recall process. Additional questions or assistance contact - +1-888-609-4839 or [email protected].