Home › Device types › CEM
Electrode, Ion Specific, Potassium
FDA product code CEM · Class 2 · Clinical Chemistry
537
Registered devices
1,008
Adverse events
63
Recalls
89
510(k) clearances
Devices with this code
Ready Sensor™ GOLD Electrode pCO2 — Siemens Healthcare Diagnostics Inc.ABL80 SC80 — Radiometer Medical ApSS8377 REF 944-136 *6 Cleaning solution Met II Solution — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSGEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST — INSTRUMENTATION LABORATORY COMPANYGEM 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 CORPORATIONISE Reference Electrolyte — Roche Diagnostics GmbHHOST 2, EPOC, JAPANESE — Epocal IncPotassium Electrode — Roche Diagnostics GmbHSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSARCHITECT — ABBOTT LABORATORIESNa/K Solution Pack — MEDICA CORPORATIONAlfa Wassermann — ALFA WASSERMANN, INC.Nova — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSpH/pCO2/pO2/Na/K/Ca Analyzer — MEDICA CORPORATIONGL Cartridge — LifehealthGENCHEM™ ISE Electrolyte Reference — GENCHEM INCABL80 SC80 — Radiometer Medical ApS
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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