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CAIRE Diagnostics

Caire Diagnostics Inc. · Model Fenom Pro · UDI-DI 00860008017901

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

Description

Package contains: External Power Supply, P/N 197-0001 Instructions for Use Reference, Fenom Pro - P/N FRM-3301

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.