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OSOM Mono 25 Test Kit

SEKISUI DIAGNOSTICS, LLC · Model 145 · UDI-DI 00742860001451

KTN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2016-06-22	Alere San Diego, Inc.	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22	Alere San Diego, Inc.	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22	Alere San Diego, Inc.	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22	Alere San Diego, Inc.	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22	Alere San Diego, Inc.	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22	Alere San Diego, Inc.	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2016-06-22	Alere San Diego, Inc.	The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
2013-02-26	Alere 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.
2006-02-14	Remel, Inc.	Some units exhibit weak false-positive reactions with some negative patient serum

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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.