FDA Device Intelligence
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Electrode, Ion Specific, Calcium

FDA product code JFP · Class 2 · Clinical Chemistry

375
Registered devices
105
Adverse events
5
Recalls
29
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 ApSE-Ca Cassette Carton — OPTI MEDICAL SYSTEMS, INC.ABL80 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.HOST 2, EPOC, JAPANESE — Epocal IncSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSpH/pCO2/pO2/Na/K/Ca Analyzer — MEDICA CORPORATIONGENCHEM™ ISE Electrolyte Reference — GENCHEM INCABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSNOVA — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONStat Profile — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONGEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANYSTAT PROFILE — NOVA BIOMEDICAL CORPORATION

Recent recalls

DateFirmReason
2021-01-06Roche Diagnostics Operations, Inc.May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit
2011-04-07Radiometer America IncBased on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membran
2008-09-05Radiometer America IncThe firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the act
2005-09-29Radiometer America IncUnder certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers
2005-09-29Radiometer America IncUnder certain circumstances, the ABL 700 &800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers i

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