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Enzyme Linked Immunoabsorbent Assay, Rubella

FDA product code LFX · Class 2 · Microbiology

67
Registered devices
761
Adverse events
15
Recalls
94
510(k) clearances

Devices with this code

Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit — Gold Standard Diagnostics CorporationBioSign® Rubella card — PRINCETON BIOMEDITECH CORPORATIONTrinity Biotech — CLARK LABORATORIES, INC.ADVIA Centaur® Rub G QC — Siemens Healthcare Diagnostics Inc.Trinity Biotech — CLARK LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDBioSign® Rubella card — PRINCETON BIOMEDITECH CORPORATIONSeraQuest — QUEST INTERNATIONAL, INC.Elecsys Rubella IgM — Roche Diagnostics GmbHTrinity Biotech — CLARK LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Atellica IM Rub G QC — Siemens Healthcare Diagnostics Inc.Diamedix — DIAMEDIX CORPORATIONTrinity Biotech — CLARK LABORATORIES, INC.ASI Rubella IgG EIA Test — ARLINGTON SCIENTIFIC, INC.ReQuest — QUEST INTERNATIONAL, INC.IMMULITE®/IMMULITE® 1000 Systems Rubella IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAccuDiag ™ — Diagnostic Automation, Inc.Trinity Biotech — CLARK LABORATORIES, INC.IMMULITE® Systems RUM CONTROL Rubella IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys Rubella IgM Immunoassay — Roche Diagnostics GmbH

Recent recalls

DateFirmReason
2021-09-22bioMerieux, Inc.bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote
2016-08-24Siemens Healthcare Diagnostics, Inc.Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for se
2016-08-24Siemens Healthcare Diagnostics, Inc.Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for se
2011-10-10Meridian Bioscience IncInternal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions a
2010-12-22BioCheck IncProduct labels indicate that the products are for IVD use and they do not have an approved 510(k).
2010-07-19Bio-Rad LaboratoriesThe EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporti
2009-12-16Diasorin Inc.DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The
2009-10-21Siemens Healthcare Diagnostics Inc.The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutof
2009-10-21Siemens Healthcare Diagnostics Inc.The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutof
2008-08-20Bio-Rad LaboratoriesElevated optical density (OD) values with the kit Negative Control.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.