FDA Device Intelligence
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Electrode, Ion Specific, Sodium

FDA product code JGS · Class 2 · Clinical Chemistry

589
Registered devices
3,996
Adverse events
48
Recalls
162
510(k) clearances

Devices with this code

NOVA — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSEPOC READER, REFURBISHED — Epocal IncSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONRAPIDPOINT® 350 Reagent Module — Siemens Healthcare Diagnostics Inc.GEM Premier 5000 PAK BG/ISE/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANYABL90 FLEX, Clot catcher — Radiometer Medical ApSMembrane for E755 electrode — Radiometer Medical ApSDisposable Waste Container D512 REF 905-590 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSDaily Cleaning Solution Kit — MEDICA CORPORATIONGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST — INSTRUMENTATION LABORATORY COMPANYSensor Module Cl- — Siemens Healthcare Diagnostics Inc.Ready Sensor™ GOLD Reference Sensor — Siemens Healthcare Diagnostics Inc.ISE ELECTROLYTE REFERENCE 88811 — CAROLINA LIQUID CHEMISTRIES CORPORATIONABL90 FLEX PLUS — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONRAPIDLab® 1200 Na+/K+/Ca++/CL- Electrode Fill — Siemens Healthcare Diagnostics Inc.RAPIDLab® 1200 Series 1245 — Siemens Healthcare Diagnostics Inc.GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANYAccessories starter kit for ABL800 FLEX — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApS

Recent recalls

DateFirmReason
2025-07-07Siemens Healthcare Diagnostics IncSiemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intend
2023-09-26Siemens Healthcare Diagnostics IncThere are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPI
2023-09-26Siemens Healthcare Diagnostics IncThere are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPI
2023-09-18Nova Biomedical CorporationPotential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential ri
2023-09-18Nova Biomedical CorporationPotential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential ri
2021-11-18Siemens Healthcare Diagnostics, Inc.(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test
2021-05-18Siemens Healthcare Diagnostics, Inc.ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current defau
2021-05-13Siemens Healthcare Diagnostics, Inc.Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in th
2021-05-04Siemens Healthcare Diagnostics, Inc.Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
2020-12-02Siemens Healthcare Diagnostics, Inc.Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

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