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CMV IgG ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-2797 · UDI-DI 04048474027976
LFZ
Prescription
1
510(k) clearances
305
Adverse events
9
Recalls
29
Facilities
Description
The DRG Cytomegalovirus (CMV) IgG ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2022-10-19 | Bio-Rad Laboratories, Inc. | Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). |
| 2017-01-11 | BioMerieux SA | 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 |
| 2015-03-26 | Diamedix Corporation | Product contained an incorrect substrate. |
| 2009-01-19 | Abbott Laboratories | Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument. |
| 2007-04-23 | Abbott Laboratories | 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 k |
| 2004-06-09 | bioMerieux | The product may give false positive results. |
| 2003-06-18 | Meridian Bioscience Inc | The Low Positive Standard kit component is losing potency that may result in false positive test results. |
| 2003-06-12 | Zeus Scientific Inc | The Calibrator included within the kit may be losing reactivity. |
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Get your free API keyRead the docsData 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.