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QuickVue+

QUIDEL CORPORATION · Model Mononucleosis Test · UDI-DI 30014613201212

KTN Prescription
1
510(k) clearances
16
Adverse events
9
Recalls
28
Facilities

Description

QuickVue+ Mononucleosis 20T

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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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.