System, Test, Infectious Mononucleosis
Immunology · 21 CFR 866.5640
Recent MDR events
16 adverse event reports on file
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07473
- MEDLINEJun 4, 2026MalfunctionMedline Industries, Lp1417592-2026-01995
- MEDLINEJun 3, 2026MalfunctionMedline Industries, Lp1417592-2026-01971
- MEDLINEMay 7, 2026MalfunctionMedline Industries, Lp1417592-2026-01003
- MEDLINEApr 3, 2026MalfunctionMedline Industries, Lp1417592-2026-00289
- BALLOON SLG 20FR X 2.0CMJun 27, 2024MalfunctionCardinal Health1423537-2024-00051
- HENRY SCHEIN MONO TEST DEVICE 20TMar 31, 2020InjuryAlere San Diego2027969-2020-00017
- ACCEAVA MONO TEST STRIP 25T (92404)Feb 6, 2020InjuryAlere San Diego, Inc.2027969-2020-00011
- CLARITY MONONUCLEOSIS RAPID TEST CASSETTENov 20, 2019MalfunctionClarity Diagnostics Llc9347166
- CLARITY MONO TESTNov 20, 2019MalfunctionClarity Diagnostics Llc9347201
Event type breakdown
Recalls
9 recall events for this product code
- Alere San Diego, Inc.TerminatedApr 18, 2013
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Z-1148-2013 · View FDA record ↗ - Remel, Inc.TerminatedApr 22, 2006
Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England
Some units exhibit weak false-positive reactions with some negative patient serum
Z-0786-06 · View FDA record ↗ - Alere San Diego, Inc.TerminatedUnknown
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bov
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Z-2265-2016 · View FDA record ↗ - Alere San Diego, Inc.TerminatedUnknown
Cardinal Health Mono Rapid Test, Catalog No. B1077-28,
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Z-2266-2016 · View FDA record ↗ - Alere San Diego, Inc.TerminatedUnknown
Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Z-2267-2016 · View FDA record ↗ - Alere San Diego, Inc.TerminatedUnknown
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selective
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Z-2268-2016 · View FDA record ↗ - Alere San Diego, Inc.TerminatedUnknown
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Z-2269-2016 · View FDA record ↗ - Alere San Diego, Inc.TerminatedUnknown
Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Z-2270-2016 · View FDA record ↗ - Alere San Diego, Inc.TerminatedUnknown
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Z-2271-2016 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Btnx Inc.
Pickering Ontario, CA
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Sanzay Corporation -
Miami Gardens, FL, US
Arlington Scientific, Inc.
SPRINGVILLE, UT, US
Teco Diagnostics
ANAHEIM, CA, US
Remel, Inc.
LENEXA, KS, US
Clarity Diagnostics, Llc
Deerfield Bch, FL, US
Stanbio Laboratory
Boerne, TX, US
Germaine Laboratories, Inc.
SAN ANTONIO, TX, US
Beckman Coulter, Inc.
Miami, FL, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Bio-rad Laboratories, Inc.
Hercules, CA, US
Sekisui Diagnostics, Llc
San Diego, CA, US
Immunostics, Inc.
Eatontown, NJ, US
Laboratorios Scantibodies, S.a. De C.v.
Tijuana Baja California, MX
Remel Europe Ltd
DARTFORD, KENT, GB
Princeton Biomeditech Corp.
Monmouth Jct, NJ, US
Sekisui Diagnostics, Llc
SAN DIEGO, CA, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Jant Pharmacal Corp.
ENCINO, CA, US
Meridian Bioscience, Inc.
Cincinnati, OH, US
510(k) clearances
59 clearances for this product code
- SEKISUI Diagnostics, LLCJun 22, 2018
K181436 · OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
- ACON Laboratories, Inc.Feb 28, 2005
K042272 · ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
- Instrumentation Laboratory COFeb 24, 2003
K030215 · BIORAPID MONONUCLEOSIS
- Instrumentation Laboratory COSep 27, 2001
K012901 · COLOR-MONOGEN
- Oxoid , Ltd.Jan 28, 1999
K982634 · DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
- Unipath , Ltd.Dec 10, 1998
K981946 · CLEARVIEW IM
- Immunostics Inc.,Dec 1, 1997
K972457 · MONOCOL/LEX-IM TEST
- Wyntek Diagnostics, Inc.Aug 26, 1997
K972231 · OSOM MONO TEST 143