Epstein-barr Virus, Other
Microbiology · 21 CFR 866.3235
Recent MDR events
4 adverse event reports on file
- EBV VCA IGGMay 7, 2014Quest International, Inc.3022521-2014-00004
- ANTI-FY (ANTI-DUFFY) FOR INDIRECT ANTIGLOBULIN TESTJul 29, 2003MalfunctionOrtho-clinical Diagnostics2250051-2003-01028
- Unnamed deviceJul 29, 2003Malfunction2250051-2003-00428
- ANTI-FYB (ANTI-DUFFY) FOR INDIRECT ANTIGLOBULIN TESTMay 15, 2003OtherOrtho-clinical Diagnostics2250051-2003-00111
Event type breakdown
Most-reported manufacturers
Recalls
7 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
Z-0735-2026 · View FDA record ↗ - Bio-Rad LaboratoriesTerminatedApr 27, 2011
BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200.
Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set Lot #46704.
Z-2082-2011 · View FDA record ↗ - Calbiotech IncTerminatedMar 5, 2010
EBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M
The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.
Z-0994-2010 · View FDA record ↗ - Bio-Rad LaboratoriesTerminatedJun 11, 2008
BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product
False negative results due to reagent packs exhibiting low signal.
Z-1157-2008 · View FDA record ↗ - Bio-Rad LaboratoriesTerminatedJun 11, 2008
BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a m
False negative results due to reagent packs exhibiting low signal.
Z-1158-2008 · View FDA record ↗ - Diasorin Inc.TerminatedMar 29, 2005
DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C
The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit.
Z-0658-05 · View FDA record ↗ - Diamedix CorporationTerminatedUnknown
Diamedix Is-EBV-VCA IgG Test Kit
A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Z-1686-2016 · View FDA record ↗
Registered firms
40 firms currently registered for this product code
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Arlington Scientific, Inc.
SPRINGVILLE, UT, US
Diasorin Italia S.p.a.
SALUGGIA Vercelli, IT
Immunocentrix Corporation
Canoga Park, CA, US
Biokit S.a.
LLISSA D AMUNT Barcelona, ES
Zeus Scientific Llc
BRANCHBURG, NJ, US
Trinity Biotech Usa
Jamestown, NY, US
Gold Standard Diagnostics, Llc
Davis, CA, US
Calbiotech, Inc.
El Cajon, CA, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Immuno Concepts, Na, Ltd.
SACRAMENTO, CA, US
Drg International, Inc.
Springfield, NJ, US
Biocare Medical, Llc
Pacheco, CA, US
510(k) clearances
56 clearances for this product code
- Biokit, S.A.Aug 7, 2024
K233606 · ADVIA Centaur EBV-VCA IgM
- DiaSorin, Inc.Jan 5, 2017
K162961 · LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
- DiaSorin, Inc.Jan 4, 2017
K162959 · LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
- Quest Intl., Inc.Jun 8, 2009
K091260 · SERAQUEST EBV EA-D IGG TEST
- Focus Diagnostics, Inc.Jul 28, 2008
K073382 · PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
- Bio-Rad Laboratories, Inc.Dec 8, 2006
K062211 · BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- Bio-Rad Laboratories, Inc.Dec 8, 2006
K062213 · BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- DiaSorin, Inc.Oct 18, 2006
K060204 · LIAISON EA IGG