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Epstein Barr Virus VCA IgM ELISA

DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-2794 · UDI-DI 04048474027945

LSE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgM test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human serum.

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2014-10-20	Diamedix Corporation	A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
2011-03-11	Bio-Rad Laboratories	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.
2008-08-27	Calbiotech Inc	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,
2007-11-13	Bio-Rad Laboratories	False negative results due to reagent packs exhibiting low signal.
2007-11-13	Bio-Rad Laboratories	False negative results due to reagent packs exhibiting low signal.
2004-11-01	Diasorin Inc.	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.

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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.