| Date Initiated by Firm | February 26, 2021 |
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| Create Date | March 19, 2021 |
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| Recall Status1 |
Terminated 3 on March 24, 2023 |
| Recall Number | Z-1284-2021 |
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| Recall Event ID |
87445 |
| 510(K)Number | K182874 |
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| Product Classification |
System, test, breath nitric oxide - Product Code MXA
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| 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. |
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| Code Information |
All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651). |
| FEI Number |
3013216353
|
Recalling Firm/
Manufacturer |
CAIRE DIAGNOSTICS INC
7020 Koll Center Pkwy
Pleasanton CA 94566-3103
|
| For Additional Information Contact | Customer Service
888-609-4839 |
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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. |
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FDA Determined
Cause 2 | Process control |
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| 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. |
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| Quantity in Commerce | 381 units (171 units U.S. and 210 units O.U.S.) |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = MXA
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