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CAIRE Diagnostics

Caire Diagnostics Inc. · Model Fenom Pro, Demo · UDI-DI 00860008017932

MXA
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities

Description

Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured as a Demo Unit Instructions for Use, Fenom Pro, US Configuration - P/N IFU-3393, as required Instructions for Use, Fenom Pro, PN IFU-3264, as required AC Power Cord Cable, US - PN 415-0003, as required AC Power Cord Cable, UK - PN 415-0004, as required AC Power Cord Cable, Switzerland, PN415-0008, as required AC Power Cord Cable, Europlug, PN 415-0011, as required

Recalls

DateFirmReason
2021-02-26CAIRE DIAGNOSTICS INCErroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readi

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.