Z-1284-2021Class II

CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** -

Name: Z-1284-2021 CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** -
Creator: Caire Diagnostics Inc
Published: 2021-02-26
License: https://open.fda.gov/license/

Caire Diagnostics, Inc. / initiated 2021-02-26 / Terminated / root cause: manufacturing process

FDA source

CAIRE DIAGNOSTICS INC began a recall of CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human... on 2021-02-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1284-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-26
Posted: 2021-03-19
Terminated: 2023-03-24
Recalling firm: Caire Diagnostics, Inc.
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.
Product code: MXA System, Test, Breath Nitric Oxide
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.
Root cause tag: manufacturing process
FDA root 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 [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].
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.
Product codes and lots: All units sold before February 23, 2021 are affected (serial numbers 100107 to 100651).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1284-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1284-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-19

Product code MXA

K182874Class IIFenom Pro Nitric Oxide TestSpirosure, Inc. / cleared 2019-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)