Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Environmental Pollutants Profile Test

Distribution without premarket approval/clearance.

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).

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.

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-quanti

Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.

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.

VIDAS CMV IgG Assay

The product may give false positive results.

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.

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.

Diamedix Is-CMV IgG Test Kit

Product contained an incorrect substrate.