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CAIRE Diagnostics

Caire Diagnostics Inc. · Model Fenom Pro Mouthpieces, Box of 50 · UDI-DI 00860008017956

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

Description

Box of 50 Fenom Pro Mouthpieces, PN 810-0006 Sold in box of 50 only, individual mouthpieces are not for retail or commercial sale Each mouthpiece is individually packaged

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.