Home › Device types › JFP
Electrode, Ion Specific, Calcium
FDA product code JFP · Class 2 · Clinical Chemistry
385
Registered devices
108
Adverse events
5
Recalls
29
510(k) clearances
Devices with this code
ABL80 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 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 COMPANYReady 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 ApSRAPIDLab® 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 ApSMembrane for E733 electrode — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-01-06 | Roche 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 |
| 2011-04-07 | Radiometer America Inc | Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membran |
| 2008-09-05 | Radiometer America Inc | The 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 |
| 2005-09-29 | Radiometer America Inc | Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers |
| 2005-09-29 | Radiometer America Inc | Under 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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