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System, Test, Infectious Mononucleosis

FDA product code KTN · Class 2 · Immunology

75
Registered devices
16
Adverse events
9
Recalls
59
510(k) clearances

Devices with this code

BioPlex 2200 — BIO-RAD LABORATORIES, INC.ASI Color Mono II Test — ARLINGTON SCIENTIFIC, INC.Detector Lex-IM — Immunostics Company, IncASI Color Mono II Test — ARLINGTON SCIENTIFIC, INC.MONOSPOT Latex — MERIDIAN BIOSCIENCE, INC.Signify® — Alere San Diego, Inc.Acceava® Mono Cassette — ALERE NORTH AMERICA, LLCSure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Rapid Response — BTNX IncDetector Lex-IM — Immunostics Company, IncBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Detector Monocol — Immunostics Company, IncCARDINAL HEALTH — Cardinal Health 200, LLCSure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Detector Color IM — Immunostics Company, IncNA — REMEL, INC.Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Detector Monocol — Immunostics Company, IncMONO, MERIDIAN IMMUNO 25 Test Kit — SEKISUI DIAGNOSTICS, LLCIcon — Beckman Coulter, Inc.ASI Color Mono II Test — ARLINGTON SCIENTIFIC, INC.Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.

Recent recalls

DateFirmReason
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22Alere San Diego, Inc.The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2013-02-26Alere San Diego, Inc.Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
2006-02-14Remel, Inc.Some units exhibit weak false-positive reactions with some negative patient serum

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.