Home › Device types › LFZ
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
FDA product code LFZ · Class 2 · Microbiology
54
Registered devices
305
Adverse events
9
Recalls
58
510(k) clearances
Devices with this code
Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit — Gold Standard Diagnostics CorporationASI CMV IgG EIA Test — ARLINGTON SCIENTIFIC, INC.Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.LIAISON® CMV IgM — DIASORIN SPAIMMULITE® 2000 Systems CVG CMV IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCMV IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungBioPlex 2200 — BIO-RAD LABORATORIES, INC.CMV IgM AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.CMV IgG AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Elecsys CMV IgM — Roche Diagnostics GmbHCMV IgG AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Atellica IM CMV IgG — Siemens Healthcare Diagnostics Inc.ReQuest — QUEST INTERNATIONAL, INC.Elecsys CMV IgM Immunoassay — Roche Diagnostics GmbHElecsys CMV IgG — Roche Diagnostics GmbHBio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.ASI CMV IgM EIA Test — ARLINGTON SCIENTIFIC, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Alinity — Abbott Ireland DiagnosticsPointe Scientific, Inc. CMV IgG — HORIBA INSTRUMENTS INCORPORATEDTrinity Biotech — CLARK LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.
Recent 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 V |
| 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 placem |
| 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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