Home › Device types › CEM
Electrode, Ion Specific, Potassium
FDA product code CEM · Class 2 · Clinical Chemistry
547
Registered devices
1,016
Adverse events
63
Recalls
89
510(k) clearances
Devices with this code
NOVA — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSEPOC READER, REFURBISHED — Epocal IncNOVA — NOVA BIOMEDICAL CORPORATIONSTAT 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 ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONMembrane 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 ApSRoche 9180 Potassium electrode — Roche Diagnostics GmbHRAPIDLab® 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 COMPANY
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-31 | Medica Corporation | A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using |
| 2025-10-30 | Inpeco S.A. | The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous result |
| 2025-10-30 | Inpeco S.A. | The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous result |
| 2025-09-03 | Inpeco S.A. | The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function h |
| 2025-09-03 | Inpeco S.A. | The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has |
| 2023-11-03 | Inpeco S.A. | Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing. |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below |
| 2023-03-10 | Inpeco S.A. | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsel |
| 2023-03-10 | Inpeco S.A. | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsel |
| 2023-03-10 | Inpeco S.A. | Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsel |
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