Home › Device types › LFX
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
BioPlex 2200 — BIO-RAD LABORATORIES, INC.SeraQuest — QUEST INTERNATIONAL, INC.Trinity Biotech — CLARK LABORATORIES, INC.Atellica IM Rub M QC — Siemens Healthcare Diagnostics Inc.Elecsys Rubella IgG — Roche Diagnostics GmbHTrinity Biotech — CLARK LABORATORIES, INC.AccuDiag ™ — Diagnostic Automation, Inc.Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSBioSign® Rubella card — PRINCETON BIOMEDITECH CORPORATIONBioSign® Rubella card — PRINCETON BIOMEDITECH CORPORATIONGold Standard Diagnostics Is-Rubella IgG ELISA Test Kit — Gold Standard Diagnostics CorporationElecsys Rubella IgM — Roche Diagnostics GmbHADVIA Centaur® Rub M — Siemens Healthcare Diagnostics Inc.Alinity — Abbott Ireland DiagnosticsASI Rubella IgM EIA Test — ARLINGTON SCIENTIFIC, INC.IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAccuDiag ™ — Diagnostic Automation, Inc.Alere Rubella-plus® — ALERE NORTH AMERICA, LLCDiamedix — DIAMEDIX CORPORATIONVIDAS® RUB IgG — BIOMERIEUX SABioPlex 2200 — BIO-RAD LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.Rubella IgG AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-22 | bioMerieux, 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 |
| 2016-08-24 | Siemens Healthcare Diagnostics, Inc. | Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for se |
| 2016-08-24 | Siemens Healthcare Diagnostics, Inc. | Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for se |
| 2011-10-10 | Meridian Bioscience Inc | Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions a |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-07-19 | Bio-Rad Laboratories | The 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 |
| 2009-12-16 | Diasorin 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 |
| 2009-10-21 | Siemens 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 |
| 2009-10-21 | Siemens 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 |
| 2008-08-20 | Bio-Rad Laboratories | Elevated optical density (OD) values with the kit Negative Control. |
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