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RELY Mono

STANBIO LABORATORY, L.P. · Model 6200-020 · UDI-DI 00657498000038

KTN Prescription
10
510(k) clearances
21
Adverse events
9
Recalls
28
Facilities

Description

For the Qualitative Detection of Infectious Mononucleosis (IM) Heterophile Antibodies in Whole blood, Serum or Plasma.

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.