Recalls for Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Distribution without premarket approval/clearance.

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

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.

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

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.

The product may give false positive results.

The Calibrator included within the kit may be losing reactivity.

The Low Positive Standard kit component is losing potency that may result in false positive test results.

Product contained an incorrect substrate.