Class 2 Device Recall Fenom Pro Asthma Monitor

• Date Initiated by Firm: February 26, 2021
• Create Date: March 19, 2021
• Recall Status: Terminated on March 24, 2023
• Recall Number: Z-1284-2021
• Recall Event ID: 87445
• 510(K)Number: K182874
• Product Classification: System, test, breath nitric oxide - Product Code MXA
• 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.
• Code Information: All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).
• Recalling Firm/ Manufacturer: CAIRE DIAGNOSTICS INC ; 7020 Koll Center Pkwy; Pleasanton CA 94566-3103
• For Additional Information Contact: Customer Service; 888-609-4839
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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 customerservice.cdx@caireinc.com. 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 customerservice.cdx@caireinc.com.
• Quantity in Commerce: 381 units (171 units U.S. and 210 units O.U.S.)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MXA and Original Applicant = Spirosure, Inc.