Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
FDA adverse event reports and recall history for enzyme linked immunoabsorbent assay, cytomegalovirus (product code LFZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 297
- Deaths
- 0
- Injuries
- 2
- Malfunctions
- 281
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-01Open, ClassifiedNo Marketing Application
Environmental Pollutants Profile Test
Distribution without premarket approval/clearance.
- 2022-12-06Open, ClassifiedNonconforming Material/Component
CMV IgM EIA, in vitro diagnostic.
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
- 2017-02-14TerminatedSoftware in the Use Environment
VIDAS 3 software v. 1.1.4
During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.
- 2009-04-15TerminatedEmployee error
AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus; list 4B47-20
Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
- 2007-07-11TerminatedOther
AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.
- 2004-07-20TerminatedOther
VIDAS CMV IgG Assay
The product may give false positive results.
- 2003-08-12TerminatedOther
Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
The Calibrator included within the kit may be losing reactivity.
- 2003-08-12TerminatedOther
Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
The Low Positive Standard kit component is losing potency that may result in false positive test results.
- TerminatedOther
Diamedix Is-CMV IgG Test Kit
Product contained an incorrect substrate.
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