Home › Device types › JGS
Electrode, Ion Specific, Sodium
FDA product code JGS · Class 2 · Clinical Chemistry
579
Registered devices
3,993
Adverse events
48
Recalls
162
510(k) clearances
Devices with this code
Ready Sensor™ GOLD Electrode pCO2 — Siemens Healthcare Diagnostics Inc.ABL80 SC80 — Radiometer Medical ApSAU — Beckman Coulter, Inc.Sodium electrode — Roche Diagnostics GmbHS8377 REF 944-136 *6 Cleaning solution Met II Solution — Radiometer Medical ApSGEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 — INSTRUMENTATION LABORATORY COMPANYABL80 SC80 — Radiometer Medical ApSADVIA® Chemistry Electrode NA — Siemens Healthcare Diagnostics Inc.GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST — INSTRUMENTATION LABORATORY COMPANYSodium electrode — Roche Diagnostics GmbHGEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANYEPOC HOST 2, CA — Epocal IncRAPIDLab® 348 Wash — Siemens Healthcare Diagnostics Inc.NOVA — NOVA BIOMEDICAL CORPORATIONHOST 2, EPOC, JAPANESE — Epocal IncSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONNormal sample rack assembly — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ABL80 SC80 — Radiometer Medical ApSARCHITECT — ABBOTT LABORATORIESNa/K Solution Pack — MEDICA CORPORATIONNova — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSpH/pCO2/pO2/Na/K/Ca Analyzer — MEDICA CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-07 | Siemens Healthcare Diagnostics Inc | Siemens 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 |
| 2023-09-26 | Siemens Healthcare Diagnostics Inc | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPI |
| 2023-09-26 | Siemens Healthcare Diagnostics Inc | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPI |
| 2023-09-18 | Nova Biomedical Corporation | Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential ri |
| 2023-09-18 | Nova Biomedical Corporation | Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential ri |
| 2021-11-18 | Siemens 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 |
| 2021-05-18 | Siemens 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 |
| 2021-05-13 | Siemens 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 |
| 2021-05-04 | Siemens Healthcare Diagnostics, Inc. | Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results |
| 2020-12-02 | Siemens 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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