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Radioimmunoassay (Two-Site Solid Phase), Ferritin

FDA product code JMG · Class 2 · Immunology

22
Registered devices
83
Adverse events
5
Recalls
24
510(k) clearances

Devices with this code

Dimension® Reaction Vessels — Siemens Healthcare Diagnostics Inc.Ferritin AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.Access Ferritin — Beckman Coulter, Inc.Ferritin AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Dimension® IMT Probe Cleaner — Siemens Healthcare Diagnostics Inc.Elecsys Ferritin — Roche Diagnostics GmbHIMMULITE®/IMMULITE® 1000 Systems FER Ferritin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® 2000 Systems FER Ferritin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®/IMMULITE® 1000 Systems FER Ferritin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAccess Ferritin — Beckman Coulter, Inc.Ferritin AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Ferritin AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Dimension® Sample Probe Cleaner — Siemens Healthcare Diagnostics Inc.Dimension® Chemistry Wash — Siemens Healthcare Diagnostics Inc.Dimension® Flex® reagent cartridge FERR — Siemens Healthcare Diagnostics Inc.Dimension® Reagent Probe Cleaner — Siemens Healthcare Diagnostics Inc.Dimension® Sample Diluent — Siemens Healthcare Diagnostics Inc.Access Ferritin Calibrators — Beckman Coulter, Inc.IMMULITE® 2000 Systems FER Ferritin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys Ferritin — Roche Diagnostics GmbHElecsys Ferritin CalSet — Roche Diagnostics GmbHElecsys Ferritin — Roche Diagnostics GmbH

Recent recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2019-07-15Siemens Healthcare Diagnostics, Inc.Negative Bias with Lot EA9227.
2017-03-10Beckman Coulter Inc.Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
2014-07-15Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, C
2013-05-06Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when usi

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